System, method and device for designing, manufacturing, and monitoring custom human-interfacing devices

ABSTRACT

A system, method and device employs sensor arrangements and an e-system in designing, manufacturing, and monitoring custom human-interfacing devices.

TECHNICAL FIELD

The present invention relates to human-interfacing devices, and moreparticularly, to a system, method and device for designing,manufacturing and monitoring custom human-interfacing devices.

BACKGROUND ART

Human-interfacing devices (HIDs) are either mass producedover-the-counter products or custom-built products. The former involvelittle or no consideration of an individual's unique musculoskeletalneeds and the latter require a time consuming, complex and costlyprocess. Both approaches assume a static system with littleconsideration of system dynamics such as changes in the individual andactivities. The traditional design process does not effectively addressthe human body's free or desired motion and can create an unnecessaryand unproductive dependency on a given HID. In the specific field oforthotic insoles, for example, incorrectly fitting orthotic insoles canresult in a dependency on the orthotic and can promote atrophy of thefoot muscles.

In addition to the above, custom HIDs are expensive and complex toproduce. For example, many custom orthotic insoles can cost at leastseveral hundred dollars and average two to three months to obtain.Additional time and cost can be incurred through various referrals topodiatrists and fine tuning of the custom orthotic. Typical fine tuningprocesses are more art than science, and primarily rely on the user'sinput, the podiatrist's abilities, and the orthotic's propensity formodification. Over-the-counter (OTC) HIDs such as orthotics aretypically much less effective than custom HIDs. While OTC orthotics aregenerally easier to obtain, assessing the need, finding a suitableorthotic, and insuring that they do not cause collateral damage areessentially impossible.

Additionally, HIDs are inherently ambiguous. There is no verifiable wayto know if they are working, to what degree, and for how long. Customorthotics, for example, rely on multiple professionals, their trainingand experience, and their level of engagement. The bio-mechanicassessment is performed in a clinical environment, prone tointerpretation, dependent on the patient performing as if in theirnatural environment, and does not consider the patient's shoes orchanges in physiology, for example. Additionally, the handoff to a thirdparty (e.g., pedorthist) increases the risk of error based oninterpretation and missing context. While a well-made orthotic insolecan have a long lifespan, for example, it exists in a dynamic systemaffected by shoe wear, changes in physiology, and activity which receivelittle, if any, consideration. This typically causes the orthotic not toperform as expected and can potentially contribute to repetitive stressinjuries, foot muscle atrophy, and less than optimal performance.

In terms of assessment, a typical assessment for determining the needfor and design of an orthotic insole, for example, can include abiomechanical and/or full gait analysis involving one or more methods,such as observation and manual measurements, pressure mapping,videography, photogrammetry, digital scanning, molds, and casts, wherepressure mapping can be accomplished through static pressure plates,in-shoe pressure sensors, and/or other wearables. Assessments for otherHIDs can involve similar analyses.

In addition to the above, current wearable devices, unless costingthousands of dollars, do not provide clinical grade data and insightfrom that data, and even the more expensive systems do not track all theneeded parameters. They do not design and monitor HIDs, any related HIDsystem or the effect of physical changes in the user. They do notaccount for user physiology, environment, activity, equipment likeshoes, performance, and form, for example. They also do no optimizeperformance in real time, measure exercise effectiveness, predictrepetitive stress injuries or identify functionally fitting equipment,apparel or other related devices. They do not connecthealth-wellness-fitness (HWF) professionals with their patients/clientsor let users share their data with HWF professionals and enable HWFprofessionals to create custom notifications and enhance theirdiagnostic and treatment capabilities. They further do not providetelemetry, for example, in conjunction with telemedicine and sportsapplications.

SUMMARY OF INVENTIVE ASPECTS

In various embodiments, the present invention provides a system, methodand device for designing, manufacturing and monitoring custom HIDs. Invarious embodiments, the system according to the present inventiongathers and stores biometric and biomechanical data via a remote device,which can be worn by an individual or placed on an HID, and transmitsthe data such that it can be processed on a mobile and/or smart devicein part or in total. The data from the wearable device or HID can betransmitted directly to a mobile communications device, computer, and/orsmart device, indirectly such as through a gateway, or from acloud-based server, for example. The data from the wearable device orHID can also be transmitted directly or indirectly via a gateway(including wireless transceiver and router, for example, where thegateway may be a part of the wearable device or independent of thewearable device), mobile device, smart device or computer to a serverfor further processing, storage in a database, and/or use by one or moreexpert systems such as provided in accordance with aspects of thepresent invention. In various embodiments, an HID can be designed andproduced in accordance with the present invention such as personallywearable HIDs (e.g., shoes, socks and other apparel), equipment (e.g.,athletic equipment, golf or tennis racket grips, keyboards, saddles, iceskates, helmets), tools (e.g., construction and gardening handles orattachments for handles) and other HIDs.

Aspects of the present invention assist with: preventing musculoskeletalinjuries, predicting repetitive stress injuries; acceleratingrehabilitation; improving the effectiveness of exercises and training;optimizing performance during competitive and non-competitive events;identifying functionally fitting apparel and equipment, including shoesand orthotics, for example; providing telemedicine and telemetryconnecting health-wellness-fitness (HWF) professionals with users,giving them access to real world data, analytics, and the ability toselect parameters and set parameter notification thresholds providing acontinuous connection to users, including access to big data analyticsand creating insights to augment diagnostic and treatment capabilities;expand the capabilities of evidence-based care; and optimizing adistributed supply chain based on a manufacturing paradigm whereanalytics identify the closest or most suitable available printer to acustomer based on customer convenience and minimal cycle time,distribution cost, and environmental concerns. In various embodiments,the system consists of a modular HID, an expert system, groupware, and amanufacturing system. The expert system according to embodiments of thepresent invention can employ an electronic sub-system (“e-system”) andsensors associated with the HID, for example.

In various specific embodiments, a modular orthotic insert according toaspects of the present invention consists of a footbed interacting withand/or containing an electronic sub-system and sensors, and a modularreplaceable orthotic/insole that can be worn with or without theelectronic footbed or e-system module as described herein. The modularinsert is a wearable sensor system used to gather and sharebiomechanical, kinematic and biometric data and fits inside a user'sshoe replacing their existing insole. The footbed is the lower portionof the insole and contains the majority or all of the electronicsrequired for the wearable to collect and transmit data. Theorthotic/insole is a custom or semi-custom part which forms theinterface between the user's foot and the electronic footbed. Theorthotic/insole may or may not have electronics in or on it.Alternatively, the e-system can be a removable cartridge similar to thatof an SD card or similar format embedded in the side of the insert underthe arch support and the sensor array mounted to the surface of theorthotic between the orthotic and orthotic cover. The sensors connect tothe e-system through the structure of the orthotic or conduitsspecifically designed for this purpose and the purpose of aligning thedifferent modules and keeping them from slipping. In an alternativeembodiment, the e-system is removable and the orthotic can be a footbedwith replaceable orthotic/insole or a single unit orthotic with thesensor system secured between a cover and the orthotic surface.

The e-system according to embodiments of the present invention cancomprise a micro controller unit (MCU), an inertial measurement unit(IMU), memory (e.g., flash memory), a radar subsystem (e.g., UWB chipsetoperable at any frequency (e.g., 30 GHz, 60 GHz, 140 GHz, etc.), acommunication subsystem (e.g., Bluetooth (BLE) chipset, cellular ormulti-mode transceiver), a power management subsystem, a battery, anenergy harvesting subsystem, and an antenna array. In variousembodiments, the antenna array can consist of a grid of fractal antennascreating a synthetic aperture radar (SAR) and uses multiple in multipleout (MIMO) and beam forming. The array collects a wide range ofbiomechanical and biometric data.

In various embodiments, the antenna array is self-healing so a user cancut through the array without damaging the system or degrading dataquality. The IMU can contain an accelerometer, gyroscope andmagnetometer, and the radar sensor system can include a signalgenerator, transceiver, and antenna array consisting of one or moreantennas. The radar sensor system can further comprise one or moretransmitter/receiver modules (TRMs) using one or more antennas with oneor more elements arranged in one of a plurality of array types. Thesystem may further contain an induction power receiver that interfaceswith the power management system and an induction charging system. Invarious embodiments, the antenna array and sensors may be integratedinto the HID. In specific orthotic insole embodiments, the antenna arrayand sensors may be integrated into the footbed, mounted between thefootbed and orthotic/insole, or located in or on the insole/orthotic.The various other electronic elements can be located in or on thefootbed, including some or all the sensors, for example.

In various embodiments, a registration system is employed to keep thecomponents aligned, including registration posts in one body (e.g., thefootbed in the orthotic insole example) and mating registrationopenings, indentations or holes in another body (e.g., the orthoticinsole in this example) such that, when mated, the posts engage theopenings to retain the two bodies together. The registration systemaccording to embodiments of the present invention prevents relativemovement between the footbed and the insert/orthotic and any layersthere between or around. In various embodiments, a hook-and-loop typeregistration system can be employed. The registration system furthersupports implementable sensor arrays by providing a method forconnecting these arrays to the related electronics. The registrationsystem can also facilitate the connection of any other electronicshoused in or on the device (e.g., to connect the orthotic insole to theelectronics in the footbed).

In various embodiments, an HID can be produced through additive orsubtractive manufacturing techniques, including, but not limited to,techniques such as 3D printing, injection molding, stamping, diecasting, computer numerical control (CNC) machining, powder processing,selective laser sintering (SLS) and spark plasma sintering (SPS), forexample. Further, the HID can be printed in more than one part, whereinone or more parts may be employed regardless of use with othercompatible parts (e.g., regardless of whether the orthotic is used witha footbed, and one or more parts are not used if the user decides towear the orthotic with the footbed).

In manufacturing a custom orthotic according to embodiments of thepresent invention, a traditional or semi-custom orthotic is insertedinto the shoe and resides atop the footbed. Once suitable data iscollected as exemplified elsewhere herein, a fully custom orthotic isproduced, and the fully custom orthotic replaces the initially insertedorthotic and is fully compatible with the existing footbed. The customorthotic serves as an interface between the footbed and the user's foot,and is designed, in part, to work with the information and expert systemof embodiments of the present invention to improve and optimize userperformance, accelerate rehabilitation, prevent repetitive stressinjuries, alleviate symptoms of other problems, and/or facilitateaccomplishment of some other relevant end goal, as described elsewhereherein. The insert (footbed plus insole/orthotic) collects userbiometric and biomechanical data when worn in a user's shoes. Thee-system and sensors can be environmentally hardened during themanufacturing process, in various embodiments, such as by encapsulatingthe e-system in the HID (e.g., footbed) during the manufacturingprocess.

According to various embodiments, a cover may be provided on theinsole/orthotic to protect the footwear, protect any electronics housedin or on the insole/orthotic and to provide a desirable surface for auser who is wearing either socks or no other clothing between the user'sbare foot and the insert. In various embodiments, the cover may be a 3Dprinted material that is printed during the manufacturing process orapplied as part of the assembly process according to aspects of thepresent invention. The cover can also function as an energy harvestingsubsystem which is capable of interfacing with the electronics in thefootbed to charge the invention in-situ, as described in more detailelsewhere herein. The insert is designed to have heat sink properties,thus enhancing the capabilities of a thermoelectric energy harvestingsystem and being able to cool or warm a user's foot.

It will be appreciated that the custom insole/orthotic according toembodiments of the present invention can be worn with or without theelectronic footbed. In the case where the user does not wish to wear thecustom orthotic with the electronic footbed, the orthotic can beinterfaced with a physical spacer with approximately the same shape andbulk mechanical properties as the footbed, but without the electroniccapabilities.

In accordance with various embodiments of the present invention, theradar sensor system antenna array may include beam forming, beamsteering, fractal antennas, phased array, variable array, and/ormultiple in multiple out (MIMO), for example. The radar system assistsin communicating biometric and biomechanics data obtained from theinsert to a smart device, computer, gateway and/or local or cloud-basedserver, for example. The radar system further can assist, along withcommunication subsystem, in providing communication between a pair ofdevices, such as a pair of orthotic inserts positioned within a relatedpair of shoes, for example.

The radar subsystem can operate in either a passive or active modewhere, in the passive mode, it utilizes compatible radio frequenciesgenerated by other sources to collect biometric and biomechanical data(for example, wireless networks, microwave transmissions, televisiontransmissions, etc.). The associated software according to the presentinvention assesses the quality of the passively collected data anddetermines if it needs to shift to an active mode.

In various embodiments, the invention can be charged using an inductionplate, and data stored, sent and received by the invention can beencrypted and compressed. The induction charging plate can be ofsufficient size to hold and charge two shoes each containing the insertsaccording to the orthotic insole exemplary embodiment of the presentinvention. The charging plate may or may not include a visual displaythat provides information on the charge state and health of objectsbeing charged. In various embodiments, the induction charging plate canbe powered either by an AC/DC converter or from a powered USB computerinterface, and is capable of accommodating 110/220 volt 50/60 Hz powersources. Embodiments of the present invention further provide fordesigning an HID to optimize the performance of the thermal dynamicenergy harvesting system.

Further, in various embodiments, the invention can fuse sensor data andconvert IMU data into quaternions. According to various embodiments ofthe present invention, data can be transmitted and synched betweenmultiple devices, such as multiple shoe inserts and third party devices,for example.

In various embodiments, the expert system component receives, stores,and processes data from a given HID, converting it into a range ofbiomechanical and biometric parameters and insights. The expert systemanalyzes incoming data while utilizing additional data streams (e.g.,internal and external) for comparisons and to make predictions about theuser of the HID, where that user can be an individual user, a team or agroup. In various embodiments, the expert system outputs data,information, and insights to an individual/team/group and to theirchosen health, wellness, fitness (HWF) and Occupational Health andSafety (OHS) professionals, peers, friends, family, fans, and othersbased on the user's privacy and engagement setting. Invited HWF and OHSprofessionals can select the functions and parameters they wish to trackwithin the constraints set by the user. These functions and parameterscan be referred to as widgets for purposes of the present disclosure.The user's constraints can be changed by the user at any time wherenotifications are sent to all affected parties. The HWF and OHSprofessionals can set notification thresholds for one or more widgetsand set notification thresholds for a group of widgets. Thesenotifications can be linked to preset, default or custom actions set upby the HWF or OHS professional such as referring the notification toanother professional within the user's team, for example. In variousembodiments, exchanges between users and HWF professionals are compliantwith laws and regulations and can seamlessly interface with third partyEMR and population health management systems, eliminating the need tomanually process exporting data, information, and/or insights, forexample.

Among other things, the expert system is capable of using real time andhistorical user data, subsets and aggregate user base data and externaldata to autonomously design human-interfacing devices. Upon userrequest, the expert system will manufacture the device, handling thetransaction, manufacturing, distribution, and any other aspects relatedto process and optimizes cycle time, environmental footprint, and cost.The manufactured device is capable of interfacing with the originaldata-gathering system allowing for confirmation of device and user andas a stand-alone device.

In various embodiments of the present invention, the expert system canconduct data analytics, draw conclusions, provide insight andrecommendations, provide a virtual coach, manage a widget store, manageapplication programming interfaces (APIs), assist with the design andmanufacturing of inserts and other human-interfacing devices, andincorporate change management components. With regard to data analytics,the system can take in data generated by a user's wearable device orother HID as well as data from other internal or external data streamsand perform various analytic processes, generate predictions andinsights and output meaningful, actionable metrics and reports viavarious widgets. The expert system coordinates and manipulates incomingdata to produce an output that is readable by the system's analyticaloperations and widgets. The data can be synced in a number of waysdepending on user preferences. This can include, but is not limited to,syncing each time a user uses the HID, when a user connects to the cloudor a network housing the expert system, every time the user interface isaccessed, or whenever the user specifically requests syncing. The expertsystem can synchronize both raw and calculated data to smart devices,computers, and other devices in various ways. In various embodiments,the expert system can learn from user interactions and offer settingmodifications that optimize user preferences or even automaticallyadjust settings according to the user's needs and desires, for example.Analytical operations and/or packages associated with the presentinvention clean incoming raw data by, for example, removing corrupteddata and outlier values beyond set thresholds. For example, once newdata is cleaned, it is appended to any preexisting data that is relevantto the incoming data stream. An analytical hierarchical function can beperformed on the dataset based on the widgets that the user/team/groupor HWF and OH&S professional have access to. Recalculations can beperformed on old data which must be updated to reflect new information.In addition, the expert system can take inputs from the user interface,such as subsetting for a time period, and either send raw data to becalculated and presented locally on a user's smart device or calculatedon or within the expert system and sent for presentationpost-calculation on a user's smart-device or other compatible device.The expert system according to embodiments of the present invention canstore both raw and calculated data locally, on a server or using adistributed storage paradigm. Data can be accessed by a user or machinethrough the user interface or relevant APIs. The expert system canoutput data, insights, suggestions and general content in a variety ofsensory formats. These may include, but are not limited to, visualoutputs, auditory outputs, and haptic feedback outputs. The system mayalso support direct stimulation of the nervous system as an output andor receive direction from the nervous system. The expert system canexport both raw and calculated datatypes in human and machine readableformats upon request through the user interface or associated APIs.

The virtual coach component of the expert system assists in facilitatingbehavioral change, motivation and achievement of user, HWF and/or OH&Sdefined goals. In various embodiments, the virtual coach component isable to use natural language processing for both input and output andprovide cognitive responses. The virtual coach is able to measure andanalyze performance data and provide predictions, insight, andsuggestions. The system can measure program effectiveness, recognizeovertraining and calculate an actual versus predicted trajectory toassist the user in optimizing performance. Further, the virtual coach iscapable of creating training plans which may include identifyingexercises and exercise modification. The virtual coach is able toprovide real-time changes and updates to the training regimen based onnewly acquired data and insights coming from the user, HWF and OH&Sprofessionals or other sources. Further, the virtual coach assists withinjury prevention, repetitive stress injury prediction, and performanceoptimization during competitive and non-competitive events.

In various embodiments, the expert system is capable of optimizing teammake-up based on specific goals and objectives. The virtual coach iscapable of emulating and enhancing the HWF diagnosis and treatmentprocess. This may include recovery and rehabilitation related virtualcoaching. The expert system is further capable of identifyingfunctionally fitting HIDs, and tracking and evaluating performance ofHIDs and related HID systems. In various embodiments, the expert systemcan identify an ideal form from a library of forms, and can optimize aform based on comparative analysis of a selected form.

In various embodiments, the virtual coach component can learn from auser's interactions with the system and the user community what the usermay prefer, what stimuli motivates the user, and user progress, assessesthe present state against the desired state, runs a sensitivity analysisand scenarios, and dynamically changes aspects of the plan to meet thegoal(s) and/or objective(s), or suggests that the user modify goal(s)and/or objective(s). The virtual coach component assesses the impact ofthe present state and any changes to the roadmap associated with aparticular goal and/or objective against any other goals and/orobjectives to obtain the most benefit from a user's actions. Further,the virtual coach component can apply its learning capabilities andaccess to big data to improve its knowledge of the user in an effort toimprove the accuracy of its recommendations and decisions. The virtualcoach component also has the capability to detect and track stress whichcan be used for, but not limited to, identify increasing stress levelsand notify an individual such as a person with autism to begin theircalming exercises, for example. The virtual coach component also has theability to identify a stress signature and, using user and otheravailable data, improve its predictive capabilities and recommendations.The virtual coach component can also provide the user with information,including but not limited to, events, activities, others in thecommunity, and/or publicly available information that enables the userto meet goal(s) and/or objective(s).

The widget store according to embodiments of the present inventioncomprises a repository of in-house and third party designed applicationsthat can be purchased by, subscribed to and given to users forutilization with their dashboards. In embodiments, users can have apersonal account that remembers their preferences and purchasinginformation should they wish to recall such information. Users can alsoaccess and utilize the widget store anonymously. In various embodiments,the widget management system can automatically optimize widgets and/ordashboards for users, including altering color schemes, changing textsizes, changing language preferences, addressing individual and userbase usage, goals, objectives and other parameters, for example.

In various embodiments, the expert system according to embodiments ofthe present invention has application programming interfaces (APIs)which have various functionalities, levels of access, and paystructures. Among other things, the expert system APIs provide a portalfor developers to interface with the expert system. The APIs alsoprovide various levels of read and write functionality with associatedsecurity and encryption levels.

With regard to design and manufacturing of HIDs according to embodimentsof the present invention, a subsystem of the expert system can beprovided that controls all aspects of the manufacturing and distributionprocess for making HIDs designed by data acquired from the invention. Invarious embodiments, the expert system is able to take user data,potentially combined with historical data or data from various otherpopulations and other external sources and autonomously design an HIDthat is custom-tailored to an individual's needs based on the user'sanatomy, physiology, activities, form, performance, environment,equipment, apparel, environment, and/or goals. The process for takingdata from a user performing dynamic activities and actions and designingany product (e.g., shoes) with a human interface can be extended fromthe same process used to make a custom HID as described elsewhereherein. The physical manufacturing process can be classified as eitheran additive or subtractive process or a hybrid of both processes, forexample. In various embodiments, the expert system is capable of takingdata from analytics and designing a human-interfacing product which ismade available for purchase by a user or HWF or OH&S professional. Theexpert system can provide users and HWF and OH&S professionals with areport detailing how and why the HID is potentially beneficial and whatpotential risks and/or side effects may be seen. The designed HIDs canbe iteratively customized with input from users and HWF and OH&Sprofessionals, for example. In various embodiments, the expert systemcontrols the manufacturing process that is either a centralized,semi-decentralized, or decentralized process where the device (e.g., afootbed) with electronic capabilities can be built using either processor combination of processes.

In various embodiments, HIDs can be produced in a centralized ordecentralized location. The production can be controlled by the expertsystem. For production in a decentralized location, the expert systemcan send all pertinent printable files, instructions and materials tothe nearest available or otherwise most appropriate location ofmanufacture to the user. For example, it will be appreciated thatsemi-custom insoles can be designed using the expert system according toaspects of the present invention, using a standard orthotic and/or usinginteraction between the expert system and a HWF professional.

In various embodiments, the expert system according to embodiments ofthe present invention can include software which handles changemanagement aspects for the user. Change management is the system foraiding users in achieving set goals, providing incentives and supportfor achieving them as well as realistic action items tailored to anindividual based on their personal profile, activities and the system'sassessment, for example. The expert system is able to gather user, HWF,and group defined goals and build a personalized program to aid users inachieving those goals. The system is able to predict cause and effect ona case-by-case basis and produce personalized suggestions. Predictionsare based on simulations and trends from the individual user as well asother relevant populations, and external sources.

In embodiments, the expert system provides personalized, desirableincentives to a user to aid them in achieving their set goals,optimizing their training, and performance such as adhering to theirplan and exceeding goals and objectives. These could, but are notlimited to, access to additional widgets, discounts, third party goodsand services, events, and awards such as achievement badges for use withthe social integration features. Among other things, the changemanagement system outputs suggestions, insights, and challenges to auser to motivate them based on, but not limited to, an assessment oftheir historical performance and external information such as usercalendar data. The change management component can interface with thevirtual coach system, and is able to utilize social pressures throughsocial integration features to motivate change. Additionally, gamemechanics can be employed to further motivate users. Suggestions by thechange management system can employ immersive gaming techniques,connecting game mechanics to real-world events and contests (e.g.,social, competitive and/or promotional) into which there can be externalintegration with the expert system. As a motivator, the performance dataof an individual can be used to influence a character in a game, virtualworld, or fantasy sport, for example. Furthermore, communication withInternet of Things (IoT) capable products can be used to influence theindividual, such as nutrition, lighting, music, room acoustics, and/orclimate, for example. Linked to vehicles, the system of embodiments ofthe present invention can incentive driving habits. The system's abilityto conduct population analysis enables it to recommend connections to auser with other users with similar goals, objectives, profiles topromote support groups, for example. Once users form a support group,they can opt-in to let the virtual coach manage the group for them,recommending activities, activity frequency, and alert team members whenan individual is at risk of not achieving a goal or objective, forexample. The change management system can be customized by a user or HWFprofessional in the case of accelerating results within a medical,sports, or enterprise environment where the latter can be focused onoccupational health and safety, wellness, or processes improvement, forexample. Further, the change management system can provide relatable,clear and actionable metrics and instructions that can be easilyinterpreted by a user through the dashboard, biofeedback, and otherinteractions.

In various embodiments, the system's front-end can consist ofnetwork-facilitated and mobile applications that provide the user withinsights, data, and biofeedback through a collection of data widgetswhich can be used independently or in combination. Data can bevisualized through a dashboard user interface that can be personalizedby the user.

In various embodiments, the functionality of the user interface comesfrom widgets. As referenced elsewhere herein, widgets are smallapplications that present specifically requested datasets to a user in aspecified manner. In various embodiments, users can subscribe tomultiple widgets that can be chosen individually or bundled together. Ifa subscription model is employed for commercial operation of aspects ofthe present invention, users can trade one widget out for anotherwithout incurring additional fees. Further, newly chosen widgets areable to retroactively access historical data so that there are no lapsesin data continuity when changing from one widget to another.

In various embodiments, a user's dashboard is made up of one or morewidgets. These widgets can be moved around (e.g., dragged and dropped)and changed by the user. A user can set up multiple dashboards, whichcan be themed, labeled and organized as seen fit by the user, forexample. Each dashboard can have multiple layers or windows. The userinterface can contain menus of administrative features which interfacewith the widget store, wherein the store is made accessible through theuser interface or a web browser, with optional social engagementfeatures, device and subscription purchasing, and user preferences, forexample. According to various aspects of the present invention, thepreferences that can be controlled include, but are not limited, todevice management, sharing and privacy settings, community, accountmanagement, profile management (user, activity, device, group), reportmanagement and other settings. Additionally, the user interface can beprovided with a first-time user workflow which is different from thestandard workflow. This first-time workflow takes first-time usersthrough the account setup process, device pairing, diagnostics andcalibration, for example.

According to various embodiments, the user interface onboards the user,preparing both the user's online profile and the user's device for usewith the expert system. The user interface facilitates data sharing,allowing a user to decide what, when, and how to share data with theindividuals and groups in their communities. The widgets that make upthe dashboards contained within the user interface are in communicationwith the expert system. The user can change the look and feel of awidget including how often the widget updates. Further, the user canobtain more detail by clicking on a widget or setting up more layers toa dashboard. Additionally, the user interface allows users to managedevice calibration, diagnostics, pairing and to see the status of theirdevices. The user interface also allows users and their approved HWF andOH&S professionals to set goals/objectives and various profiles fordifferent activities and devices. The user interface further has theability to recover a user's account and account information.

From a community perspective, the user interface allows users to selectwho within their networks of HWF professionals, family, friends,colleagues, fans, researchers, and research projects can see what typesof data and under what conditions. Additionally, users are able tospecify which subsets of each data type are shared. The user interfacecan further contain processes to allow users to share data with selectedgroups and individuals on a time basis, project basis, event basis orindefinite basis. It will be appreciated that the share and privacysettings can be changed at any time by the user. Further, the userinterface includes functionality which allows users to volunteer theirde-identified data for research purposes and research projects. Forexample, in the case of HWF and OH&S professionals, such professionalscan access data volunteered by the user base. Further, HWF and OH&Sprofessionals can issue the insert and, as described above, setupwidgets and dashboards. Further, HWF and OH&S professionals can set up adashboard to track multiple users where the expert system can provideinsights based on one or more participating users, de-identified data,and external input. In various embodiments, the system provides aclearinghouse (crowdhealing) for researchers and users, allowingresearchers, HWF professionals, academics, and enterprises to post theirprojects, letting users volunteer to share their de-identified data.Alternatively, users can select projects in which they want toparticipate through a manual search or by recommendations from theexpert system. This clearinghouse extends evidence-based care informingdiagnostics, treatment, and performance optimization. The projects mayor may not include some form of incentive, in various aspects.

In various embodiments, the system of the present invention designs andmonitors custom HIDs based on data from the HID and/or a personal device(e.g., a wearable device), improving its accuracy over time and as theuser base increases, with or without input from HWF and OH&Sprofessionals. Among other things, the system can assess form to preventrepetitive stress injuries, accelerate rehabilitation, measure exerciseand training effectiveness, optimize individual and team performance,predict treatment outcomes and success. The system can accommodatemultiple levels of processing with real time processing taking placethrough the mobile app and its host device, near real time and postevent processing in the cloud. It will be appreciated that real timeprocessing can also take place entirely within the insert and/or smartdevice, with or without the server, according to embodiments of theinvention. In various embodiments, the system's back-end provides datastorage, management, and processing. Software in the form of groupwarecan also be provided as a back-end service accessed through the web andmobile apps, and can employ third party collaborative tools such asvideo conferencing, email, text, and voice to connect users with theircommunities. The groupware can also enable health-wellness-fitnessprofessionals to let the system provide insight and recommendations orto manually select and track parameters, create notification thresholds,and run analytics based on a user's real world data, historical data,across their patient/client base, within their medical system, andacross the entire user base.

In various embodiments, an additive and/or subtractive manufacturingsystem component associated with the present invention providese-commerce capability, resource planning, inventory management, supplychain management including notifications to users on order status andreminders, based on system data, to order new HIDs, such as orthotics,for example.

In various embodiments, a custom HID can be designed and manufacturedbased on user activity without requiring human intervention. Thecollected data is analyzed by the software which generates a printable3D model of the custom HID, creates a report for the user, identifies aprinter most convenient or suitable to the customer and sends the 3Dmodel and any instructions for printing. The system can notify the userof progress and delivery options. A technician can perform a qualitycheck of the printed HID, perform finish work, and package the HID fordelivery.

In various embodiments, the invention can be used to measure theperformance of a user's HID and identify and optimize functionallyfitting accessories and/or be incorporated into accessories madeavailable for purchase. Aspects of the invention can be used to providehealth-wellness-fitness (HWF) and occupational health and safety (OH&S)professionals continuous real world data about their patients/clients,giving them the ability to improve the quality of their engagement,improve accessibility, increase the speed and accuracy of theirdiagnostics and treatment, and predict treatment outcomes, such as theneed for surgery and its near- and long-term outcome(s), for example.Embodiments of the present invention can be used by HWF and OH&Sprofessionals to improve productivity enabling prevention through earlydetection, behavioral awareness, and responsibility delegation, whichcan provide alternatives for a user who may otherwise require an officevisit. Embodiments of the present invention can also be used to monitorand self-monitor a user's HWF and enable a user to request emergencyresponse, such as an athlete injured during training, an individualfeeling unsafe and/or an injured or at risk elderly person, for example.Embodiments of the present invention can be used by athletes and teamsto improve the effectiveness of their exercises and training andoptimizing performance during competitive events.

Embodiments of the present invention can be used by coaches and trainersto optimize individual and team performance, reduce the risk of injuryand accelerate rehabilitation. Embodiments of the present invention canbe used by medical professionals and researchers to understand andoptimize the efficacy of diagnostics and treatment by using theinventions analytical and groupware capabilities to gain and distributeinsights from the real world data. Embodiments of the present inventioncan be used by individuals to identify functionally fitting HIDs (e.g.,shoes) and businesses within the related device (e.g., footwear) supplychain to provide a personalized fitting experience offeringoff-the-shelf custom HIDs, for example. Embodiments of the presentinvention can be used by military and law enforcement to reduce specificHID-related issues and optimize individual and team performance.Embodiments of the present invention can be used to predict and counterrepetitive stress injuries. Further, embodiments of the presentinvention can be used to customize off-the-shelf HIDs. Embodiments ofthe present invention can also be used by individuals with medicalissues that manifest symptoms or indicators such as diabetes, arthritis,neuropathy, stroke, and dementia to identify and prevent issues andbehaviors that may diminish their quality of life and number or severityof symptoms, for example.

Embodiments of the present invention can be used to provide locationservices and data to HWF and OH&S professionals. Embodiments of thepresent invention can be used as a tool to enhance data collection inclinical trials. Embodiments of the present invention can be used topredict the outcome of treatment options such as recovery rate andlong-term results of physical therapy and surgery. Embodiments of thepresent invention can be used by HWF professionals to collect real worlduser data based on specific or generic activities such as athletic,work, recreational, and daily activities. Embodiments of the presentinvention can be used in training and fitness facilities to track andimprove the efficacy of exercise, optimize form, recommend changes tothe regimen, predict repetitive stress injuries, and assess theregimen's ability to meet objectives. Embodiments of the presentinvention can be used for both indoor and outdoor activities and inclinical and non-clinical environments.

In various embodiments, the present invention provides a digitalmaterialization system, device and method that can describe, create,monitor and manipulate a physical object using data collected bysensors, digital libraries, and digital feedback. Such can be used by anexpert system in accordance with aspects of the present invention todesign, validate, and fabricate the physical object, where datacollected from the use of that physical object updates the digitallibraries and can contribute to the modification of the physical objecton an ongoing basis as appropriate. The modification process can presentitself as a discrete activity initiated by a request or can occurautomatically by either generating a new physical object or the physicalobject modifying itself, according to various aspects of the presentinvention. An example of the latter can involve an orthotic that adjustsone or more properties to optimize a set of criteria such as a footorthotic using artificial muscles to modify itself in an effort tooptimize free motion, prevent repetitive stress injuries and/or optimizeperformance. The sensor data can include, but not be limited to,biometric, kinematic, biomechanical, environmental and object data. Thedigital libraries can include, but not be limited to, materials, models,biomechanical, kinematic, and behavioral libraries, for example. Digitalfeedback in the form of qualitative and quantitative input can include,but not be limited to, user satisfaction, observations forprofessionals, measurements from other systems, scraping the internetfor content pertinent to the user's interest and activity and, in thecase of the HWF professional, enhancing evidence-based care, forexample. The dynamic digital materialization according to aspects of thepresent invention provides a deeper understanding and sophisticatedmanipulation of matter without the intervention of humans during thedesign, validation, fabrication, data collection, and library managementprocesses. This results in rigorous digital descriptions of physicalobjects that, in conjunction with the system's expertise, can adapt anobject to a user's personal needs and preferences.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exemplary architectural diagram illustrating communicationsand functional elements associated with embodiments of the system of thepresent invention.

FIGS. 2 and 3 are schematic diagrams illustrating system componentsaccording to embodiments of the present invention.

FIG. 4 is a schematic diagram illustrating elements of an e-systemcomponent according to embodiments of the present invention.

FIG. 5 shows diagrams of representative sensors according to embodimentsof the present invention.

FIG. 6 is a flow diagram illustrating various software processesaccording to embodiments of the present invention.

FIG. 7 is a flow diagram illustrating an optimization process accordingto embodiments of the present invention.

FIG. 8 is a flow diagram illustrating processes according to embodimentsof the present invention.

FIG. 9 is a flow diagram illustrating a virtual coach process accordingto embodiments of the present invention.

FIG. 10 is a flow diagram illustrating a custom insole constructionprocess according to embodiments of the present invention.

FIG. 11 is a flow diagram illustrating a widget store process accordingto embodiments of the present invention.

FIG. 12 is a flow diagram illustrating a fall prevention processaccording to embodiments of the present invention.

FIG. 13 is a side view of a schematic diagram illustrating components ofa device according to embodiments of the present invention.

FIG. 14 is a top view of a schematic diagram illustrating components ofa footbed according to embodiments of the present invention.

FIGS. 15 through 17 show schematic embodiments of different componentcombinations of a device according to aspects of the present invention.

FIG. 18 is a flow diagram illustrating a custom orthotic insole creationprocess according to embodiments of the present invention.

FIGS. 19 through 37 are an exemplary user interfaces associated withembodiments of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS

As depicted in FIGS. 1 through 19, embodiments of the present inventionprovide a system 40 including a human interfacing device (HID) 10communicatively coupled to a hub 12 and a remote central server 20. Asillustrated in FIG. 1, the central server 20 can comprise at least oneprocessor, memory and programming operable to direct the processor toperform various functions, including administrative component 21 formanaging user interactions, including registration, requests andfeedback, widget component 22 for offering functional widgets, analyticscomponent 23 for performing analytics, API component 24 for offeringvarious APIs, widget optimizer component 25 for offering customizationand optimization functions for various widgets made available throughwidget component 22, native device and web applications 26, designcomponent 27 for generating HID designs, manufacturing component 28 forinstructing the manufacturing of various HID designs, including managingadditive and subtractive printers and printer technologies, printermaintenance and supplies, and coordinating printer vendors andsuppliers, distribution component 29 for managing the distribution offiles, data and end user delivery of completed HID products, and coachcomponent 30 for managing recommendations, training, injury preventionand other aspects on behalf of other users and beneficiaries of HIDs inaccordance with the overall embodiments of the present invention. Otherfunctional components can be provided as part of server 20 or asexternal systems 35 accessible to server 20, including transactionprocessing, e-commerce, publications, product offers, customerengagement and other functions associated with embodiments of thepresent invention. The server 20 holds and/or can access all of thelibraries (represented generally at 33 in FIG. 1) associated with thepresent invention, including those identified in the digitalmaterialization (DM) and/or dynamic digital materialization (DDM)processes described elsewhere herein.

At least one e-system 14, as shown in FIGS. 2 through 4, can be embeddedwithin an HID, or maintained as physically separated from, butcommunicatively coupled to the HID 10, remote server 20, smart device 92and/or other computing device 90, wherein the e-system 14 comprises atleast one micro controller unit (MCU) 50, a radar sensor subsystem(e.g., Transmitter Receiver Module (TRM) or gateway 52), a memory 54,and a power management system 64 which incorporates a battery forproviding power to the e-system and additional include an energyharvesting subsystem. The e-system 14 may be co-located with one or moresensors 305 a-n interfacing with the e-system 14 through a wired orwireless connection to the gateway 52. The sensors 305 a-n can begrouped into sensor arrays, such as arrays 310 a and 310 b, or may beindependent sensors as 305 n. The sensors can receive controlinformation from the e-system 14, and can provide signal data back tothe e-system 14 via gateway 52. A signal/control processor (SCP) 53manages these communications with MCU 50 and can include independent SCPmemory 80. The SCP 53 performs signal and control processing related tothe sensors and manages local system and data management, with theability to conduct some or all analytics locally. As shown in FIG. 4,the sensors can include sensors (indicated generally at 305) secured toan HID, as well as external sensors 315 that may be provided as part ofan external item, such as a wearable technological device generatingdata employable by the present invention for any of the various purposesdescribed herein.

The e-system 14 can operate passively or actively (e.g., defaulting topassive) based on the availability of non-cooperative sources such astelevision, cellular, wireless, and radar transmissions. The e-system 14can adaptively adjust signal strength, modulate signals, modifywaveforms including, but not limited to, transmitting and receivingmultiple modes, modulations, waveforms and frequencies simultaneously orsequentially. As shown in FIG. 3, the sensors are capable of forming oneor more sensor arrays 310 a, 310 b in conjunction with or without ane-system 14. In the case of the former, a sensor inertial measurementunit (IMU) is not required but can be used in situations where thesurface supporting the sensors forming the sensor array is not stable orconsistent. In the latter, a single sensor can be assigned as masterwith respect to both the IMU and TRM or one or the other with the othersensors operating as slaves within the chosen mode. The master statuscan also apply to communicating with an e-system 14 where the mastersensor acts as an intermediate hub or gateway, for example. Among otherthings, the sensor array can provide sufficient data to the e-system 14to identify its position in relation to the e-system 14 and othersensors. In various embodiments, the e-system 14 adaptively forms andsteers beams directing one or more antennas and or antenna arrays tooptimize transmission and reception as well as assigning independenttasks to one or more antennas such as targeting features of interest,communicating with the e-system 14, forming a mesh network, and sweepingareas of interest, for example. The e-system 14 is capable of using oneor more antenna arrays as a real or synthetic aperture, and is furthercapable of implementing Multiple In, Multiple Out (MIMO) and distributedMIMO using multiple sensors. An antenna array 60 (shown in FIGS. 13 and15-17) can comprise one or more fractal antennas capable of ultrawideband and sub-band transmission and reception, where ultra widebandis defined as emitted signal bandwidth exceeds the lesser of 500 MHz or20% of fractional bandwidth.

In addition, the e-system 14 can adaptively control and coordinatesensors, optimizing characteristics such as, but not limited to, powerand resolution using such capabilities selecting from a variety of modesand modulations and, in the case of passive coherent location (PCL)mode, selecting a reference sensor. The e-system 14 can adaptivelydetermine levels of sensor autonomy, and can adaptively process sensordata to optimize such characteristics as, but not limited to, imageresolution. As shown in FIG. 2, the e-system 14 can communicate withremote devices (e.g., 20, 90, 92) wirelessly, such as through a gatewayor hub (e.g., hub 12 in FIG. 1), for purposes such as, but not limitedto, permanent data storage, dashboard administration and maintenance,analytics, and community interaction such as linking with HWFprofessionals as described elsewhere herein. Various outputs can includevisual 320, auditory 322, kinesthetic/haptic 324 and inertial 326 forthe purpose of status, diagnostics, biofeedback, and system interaction.The e-system 14 can map locations of sensors with sufficient accuracy toenable analytics and expert systems to adjust for any sensormisalignments, and further can support the continual refinement ofanalytical models such as kinematic and biomechanics models in the caseof health wellness fitness applications. In alternative embodiments, thee-system 14 can be in a form factor that fits on the wrist, arm, leg, orhead. In the latter embodiment, the e-system 14 can be integrated intoor attached to eyewear providing a heads-up display through a clearOLED-based screen that is applied to an existing lens or acts as thelens, not a projection system, as well as other interactions such ashaptic and audio where audio could include voice commands, for example.In such embodiment, the OLED-based screen could also provide tinting toimprove vision in bright setting, for accuracy, and for accurate colorrendition, optionally with sunglasses accentuating different sections ofthe color spectrum based on the various manufacturing processes forsunglass lenses.

As shown in FIG. 5, a basic sensor module 305 is shown at 501 caninclude one or more Transmit Receive Modules (TRM) and one or moreantennas which can comprise one or more antenna arrays. In variousembodiments, the sensor module and or the sensor array can operate asone or more monostatic, psuedo-monostatic, bistatic, or multistaticsystems. IMU supports sensor mapping and physical changes in thesensor's orientation and position with respect to the target, such as,for example, changes to the sensor's position on an article of clothing,in a shoe, direct contact with the body. The module 305 shown at 501 canbe employed in a sensor architecture for use in a sensor array wheresensors are co-located and hardwired to an e-system, for example. Thesensor module 305 shown at 502 can be employed in a sensor architecturefor use in a sensor array where sensors are co-located, with a hardwiredor wireless connection to an e-system, and require local signal andcontrol processing via the SCP component of the module 305 shown at 502.In various embodiments, this arrangement can be deployed as anintegrated chipset, for example. The sensor module 305 shown at 503 canbe employed in a sensor architecture for use in a sensor array wheresensors are distributed and connected wirelessly to an e-system, forexample, where the sensor 305 includes a TRM, an IMU and an antennaarray. The sensor module 305 shown at 504 can be employed in a sensorarchitecture for use in a sensor array where sensors are distributed,connected wirelessly to an e-system, and require local signal andcontrol processing, where the sensor 305 includes a TRM, IMU and SCP asshown.

With reference to FIGS. 1 and 6-8, the present invention provides, amongother things, a system 40 that operates to inform a wide variety ofcomponents for various purposes. For example, database 33 (representedgenerally in FIG. 1) can store various libraries such as a parameterlibrary 331, process library 332, kinematic model library 333, usercharacteristics library 334 and historical user data library 335. Table1 below provides details of various types of parameters that can beincluded in parameter library 331 and tracked according to embodimentsof the present invention.

TABLE 1 Force Shear AHRS Biometric Pressure Shear Orientation (planarposition) Navicular drop Amount Amount Position Muscle activationLocation Location Dead reckoning Joint and bone movement Line DirectionElevation Blood pressure Center Gradient Pace/Distance Traveled Bloodflow Peak pressure Duration Gait speed Oxygenation (O2) Location PinchShear Phase speed O2 Saturation Duration Amount Acceleration Pulse Peakpressure gradient Location Base Width Caloric burn Transverse GradientCenter of Balance Hydration Anteroposterior to frontal DurationPreferred Line of Balance Foot shape and dimensions Zone-to-Zone PeakShear Stress Frontal Performance Pressure time integral Amount SagittalForm Power/Torque Location Mediolateral Fatigue Contact phase durationGradient Instability Risk, repetitive stress injury Swing phase durationDuration Amount Speed Gait length Depth Location Endurance Gait durationIntra/Inter-foot comparison Line Capability/Capacity Steps takenComposite Directional changes Agitation/Emotional stressIntra/Inter-foot comparison Great toe flexion Fall risk CompositeIntra/Inter-foot comparison Intra/Inter-foot comparison CompositeComposite

Process library 332 can include, for example, detailed algorithms forevaluating data in the database according to different requestedpurposes, such as, for example, managing or preventing repetitive stressinjuries, generating an orthotic design for manufacturing, managing userperformance, optimizing HID fitting, supporting rehabilitation efforts,improving exercise/workout effectiveness, facilitating virtual coaching,predicting bodily falls, assessing location, performing gait analysis,assessing form, assessing stress, performing research, supportingoccupational health analysis, and/or providing an information dashboard.

FIG. 6 illustrates how parameters and functions are evolved inaccordance with embodiments of the present invention. As shown therein,raw data 601 can be entered into the database (through admin component21 of server 20, for example) representing, for example, past studies,historical user data, baseline parameters, baseline process algorithmsand similar items. An external request (such as through admin component21) can be received, or an internal request can be received, as at 603,instructing the system to initiate a requested process as at 605. Asubset of organized data relevant to the request, i.e., “tidy” data, ispulled and/or derived as at 607, the relevant parameter library orlibraries are accessed as at 609 and parameter information is calculatedas at 611. For an initial request, parameter calculations may beassessed based upon the request. For example, if a request is to run aprocess to predict repetitive stress injuries for a given operation oruse of a given HID such as an orthotic insole, the present invention mayoperate to employ various force, shear, AHRS and biometric parameters asidentified in Table 1 above. Various process algorithms 613 a-613 n canthen be run to address the request and targeted output 615. The output615 can include, for example, diagnosis and treatment 617, prediction619, biofeedback 621 and publishing results to a user dashboard 623, forexample. Internal 625 and external 627 feedback, such as qualitativedata from a user or coach, for example, can be employed to inform theoptimization processes 629 according to embodiments of the presentinvention, and the resulting information from the running processes andinputs can be continually fed to the database 33 to inform futureactivities and processes, both for the requesting user for the specificoutput, as well as for future users with overlapping scenarios,requests, outputs, parameters and/or processes, for example. In thisway, the collective knowledge and wisdom of the system 40 is continuallyimproved.

FIG. 7 illustrates process steps involved in the optimization routines629 of FIG. 6, according to various embodiments of the presentinvention. As shown therein, external feedback 627 can encompass health,wellness and fitness (HWF) professional feedback 6271, user qualitativefeedback 6272, third party feedback 6273, environmental feedback 6274,manager feedback 6275, coach feedback 6276 and community feedback 6277,and such feedback can be stored in the database as indicated at 633.Similarly, system data and/or internal feedback 625 can be collected,and can be combined with external feedback 627 to validate systemresults as at 711 for requested processes, for example. At 713, suchresults can be compared with system predicted outcomes pulled from thedatabase as at 709, and updated models, processes and parameters can beproduced as at 715 for current and later use. In comparing the systemresults and predicted outcomes at 713, the appropriate kinematic model333 from database 33 can be accessed, the system results can beaccessed, a comparative algorithm can be run to identify statisticallysignificant differences between system results and predicted outcomes,and the results can be stored.

In producing updated models, an updated process library and/or anupdated parameter library as at 715, results can be pulled as at 709,and variables can be replaced in the relevant models to supports systemresults. For example, kinematic, burn rate, goal trajectory, and finiteelement variables can be replaced. If, after multiple iterations, themodels and algorithms according to the present invention are not able topredict the system results as desired, the variables in the processlibrary algorithms can be replaced in order to more accurately predictthe system results. Further, if, after multiple iterations of theprocess library updates aren't able to predict system results, replacevariables in parameter library algorithms to accurately predict thesystem results.

In terms of system evolution, processes can be employed whereby a largenumber (e.g., 1000) copies of the models, process library, and parameterlibrary are generated, variables are randomly changed within each model,process and parameter library, the accuracy of the randomized models,process and parameter libraries are evaluated by comparing the systemresults, original predicted outcomes, and randomized model outcomes, atop percentage (e.g., fifty percent) of the most accurate models arepaired, and multiple (e.g., two) “child” model, process and parameterlibraries are generated which share randomly selected characteristicsfrom the paired “parent” models. This process of randomly changingvariables within each model, process and parameter library to generate atwo “child” model, process and parameter libraries which share randomlyselected characteristics from the paired “parent” models can be repeateduntil a more accurate model, process, and parameter library isgenerated.

System variables can also be updated as a result, as at 717. In theprocess, the global update of variables 719 for the parameter library331 can include updating current parameters as at 340 and adding newparameters as at 341. The global, group and/or individual update ofvariables 725 for the kinematic models 333 can include updating currentmodels as at 343 and adding new and/or extending the models as at 344.The global, group and/or individual update of variables 725 for theprocess library 332 can include updating thresholds 350, which caninclude updating a range of thresholds 351, adding new thresholds 352and/or removing thresholds 353. Such operations can also includeupdating variable weightings as at 354 and updating algorithms as at355, which can include adding algorithms 356, combing algorithms 357,re-ordering algorithms 358 and removing algorithms 359, for example.

FIG. 8 illustrates a process for digital materialization of an HID inaccordance with embodiments of the present invention. As noted elsewhereherein, an HID can be a wearable device, such as a glove, and can alsobe a non-wearable device, such as handle or grip, or even a device thatinteroperates between a human part and a non-human part. For example, anHID can be an attachment to a grip or handle that is not worn and thatis not the actual grip or handle. As shown in FIG. 8, a user request 801and/or a third party request 802 is received by the system (e.g.,through admin component 21) and the system 40 determines whether theobject already generally exists as at 805 in the system database 33. Inmaking the request, the user can identify a purpose associated with thedesign of the object, including purposes such as injury prediction,performance enhancement, rehabilitation, symptom reduction, productevaluation and/or adapting performance to more closely match anotherhuman being (e.g., to play tennis more like a specific professionaltennis player).

If the object already generally exists, the system pulls the generalobject from a relevant library 804 as at step 807, and then simulates asat step 809 and evaluates at step 811 in order to determine whether andwhat customizations may be necessary to the object in order to optimizethe object as at step 813. It will be appreciated that the stored objectmay be a general object or a specific object (e.g., tennis racket gripsin general, or tennis racket grips associated with male human beingsabove five feet, ten inches in height with mild forms of arthritis. Inother words, the system can call up most compatible users in obtainingspecific objects that may be most opportune for use with a given user'srequest.

With reference back to FIG. 8, if it is determined that optimization isbeneficial, then analytics 23 and/or coach component 30 can run adetailed simulation. Such component(s) will then evaluate the simulationusing the most current optimization criteria, updating the criteria asappropriate. In performing the simulation step 809, the system can pullrelevant information from relevant libraries 808, such as, for example,the user's physical statistics, past injuries, and feedback associatedwith others' uses of the same and similar objects, among other things.

In various embodiments where multiple sensor arrays are in use, such asin an orthotic insole sensor system described elsewhere herein, or asensor system in the shaft of a racket, for example, the digitalmaterialization process according to the present invention can conduct amulti-body optimization, where the insole and racket are both optimizedto, for example, improve the performance of an individual playing tennisby collecting data on the individual's form, results, and equipment andoptimizing the design to compensate for deficiencies in the individual'sform to improve results.

In the case of shoes, the user can wear an intelligent insert associatedwith the present invention and, based on the data collected and storedin the various digital libraries, such as, for example, user profilelibrary, preferred and actual form library, kinematic and biomechanicalmodels library, object library (in this case an insole/orthotic),parameters library, analytics library, virtual coach library, materialslibrary, shape library, behavior library, and manufacturing/distributionlibraries.

In the case of a handheld device with a shaft, the sensors can beinserted into the base of the device such as a racket, applied to theracket shaft under or over the grip, and worn as a glove, for example.This approach extends to other devices such as saddle where the sensorscould be worn under the saddle, on the surface of the saddle, and/or inclothing. Attaching sensors to the equipment may be preferred in variousembodiments. However, such approach may not be practical with smalleritems such as writing and kitchen utensils. In these cases, the sensorscan be worn by the user.

Returning to FIG. 8, if the system determines that the device should bemodified for optimization at step 813, then the device is modified as at815 and the simulation and evaluation steps are again performed untiloptimization standards are met. If the object can be optimized, then itsshape, structure, and or material(s) are changed. Simulations andevaluations are run repeatedly until the object has been optimized,after which it is saved in the digital library, a notification is sentto the requestor (e.g., the user or system 40). As part of theevaluation process step 811, an assessment is made as at step 821 as towhether the underlying criteria require updating from appropriatecriteria libraries 820. If not, the criteria are deemed to be optimalfor the current process as at step 823. If so, the criteria areoptimized as at step 825 and updated as at 827 for use with theevaluation step 811 and further for use in updating the libraries 820.Criteria optimizing at step 825 and libraries 820 further inform thecreation of a new HID object as at step 806, should it be determined atstep 805 that the requested object does not currently exist in thesystem database. In various embodiments, the two-step evaluation processcan be reduced to a single step, where the initial evaluation iseliminated and the object goes directly to the simulation step.

Referring back to the optimization step 813, if the object requires nofurther optimization, it is saved as at step 831 and stored in therelevant digital library/libraries 812, and the requestor is thennotified that the optimized design for the object has been completed, asat step 833.

The designed object can further be communicated to the user for approvalas at step 835. If the object is not approved by the user, the requestorcan be notified as at step 833. If the requestor is the user himself orherself, then such user will already know the device has not beenapproved and the arrow 834 to step 833 need not be involved. If the userapproves the design at step 835, then installation and/or usageinstructions can be generated as at step 837, and a design/manufacturingfile can be produced as at step 839. Such file and/or information canthen be transmitted to a fabrication component or system as at step 841in order to produce the HID as designed.

As an alternative to the operation of FIG. 8, the present invention canincorporate output into the HID itself, wherein the HID is adapted to beable to morph its physical form somehow based upon the optimizationprocess in 813. This dynamic digital materialization process causes thephysical object to morph. For example, the morphable HID can be anactive shoe insert or shoe that uses artificial muscle to change thecontours of the insole and its properties, or can be an active gripmorphing to reduce risk of injury and extend and/or enhance performance.In this embodiment, the fabrication and distribution functions are nolonger required, as they are replaced by adaptive materials andsurfaces.

FIG. 9 illustrates a sample process flow associated with virtual coachcomponent 30 according to embodiments of the present invention. As showntherein, goals and/or goal information 901 can be stored in the systemof the present invention as at 903. The user's performance is monitoredat step 905, and external data can be monitored as at step 907,including such data as may be provided by a HWF professional, the useror another as at 908, for example. Goals can then be compared toperformance as at step 909, and a determination can be made by analyticscomponent 23 as to whether the user is on track at step 911. If so, theprevious monitoring steps are repeated as indicated by arrow 912. Ifnot, real-time feedback can be provided to the user at step 913, such asby communicating with the user's computing device, for example.

FIG. 10 illustrates further details associated with an expert systemsuch as system 40 of the present invention. As shown therein, the system40 collects various information and feedback from the system and any HIDand related sensors involved, noted at 977, as well as external feedbackat 978 and user feedback at 979. The system 40 stores the data in one ofseveral digital libraries 33 including, but not limited to, user data,parameters, analytics, digital materialization objects, activities, userform, various models, range of material characteristics, manufacturing,and distribution data, for example. The digital materialization processcan occur based on the libraries to create an HID design file, as at980. Fabrication at step 982 and distribution at 984 can bring the HIDproduct to the user, whereupon data regarding the use of the fabricatedHID by the user can be recorded and stored in libraries 33.

Regardless of the object being fabricated, upon a request by the user orexpert system via component 21, for example, the digital materialization(DM) process searches the digital library 33 for an appropriate DMobject (e.g., the existing DM object will be the most recently modifiedDM object). When located, the system 40 loads the DM object along withis associated characteristics from related libraries including, but notlimited to, materials, shape, behavior, manufacturing/distribution,models, forms, and user information libraries, for example.

If an appropriate DM object is not available, then the expert systemuses the data from all the digital libraries to create a default objectcombining information gathered from external sources such as theInternet and/or information already stored in a library, as shown anddescribed in connection with FIG. 8. The existing or newly generated DMobject and associated data is then assessed by the expert system todetermine if it needs to be optimized, as shown and described inconnection with FIG. 8.

FIG. 11 illustrates a sample process flow associated with widgetcomponent 22 according to embodiments of the present invention. As showntherein, user account information is obtained as at 920, and userpreferences are processed as at 922. The user's current inventory ofsubscribed widgets is then shown at 924. If the user desires to purchaseadditional widgets at step 926, the transaction is fulfilled as at 928,the user account is updated as at 930, and the widget is added to theuser's inventory as at 930 so that the user may then manipulate thewidget as desired in the user's dashboard or other widget display, forexample. If the user does not wish to purchase a widget at 926, then theuser is prompted to exit at 927, and given the option to return to thedisplay of current widget inventory at 924. Otherwise, if the userdesires to exit, the process completes at step 932.

FIG. 12 illustrates a sample process flow associated with fallprevention, as may be employed as a safety measure for personssusceptible to falling due to injury, advanced age or other condition.As shown therein, live data 940 and remotely held data, such ascloud-stored data 942 are captured and fall-associated parameters areaccessed as at 944. Based on the information and parameters, analyticscomponent 23 determines where the person is at risk at step 946. If so,a suitable report is prepared and transmitted as at step 948. If not,the relevant data is reported to cloud storage as indicated by arrow949.

It will be appreciated that the process for fabricating products usingdigital materialization in accordance with the present invention can beconsistent, whether the product is a glove, saddle, grip, helmet ororthotic, for example. In various embodiments, the user wears a sensorsystem, such as an intelligent modular insole described below, orattached to other body parts such as various positions on the legs,arms, torso, and/or head. The sensors can also be mounted inside theshaft a tool, sports equipment, garden equipment, protective gear, etc.,where the data collected can be used to design a personalized ergonomicfit and or re-design the item to optimize performance, such as, but notlimited to, a tennis racket, golf club, saddles, handlebars, furniture,seating, garden tool, protective gear, kitchen utensils, medical tools,and construction tools/equipment.

Exemplary Case: Orthotic Insole

As shown in FIGS. 13 through 19, specific embodiments of the presentinvention comprise a device 100 and system for use with customorthotics. The device can comprise a footbed 212 formed with at leastone footbed e-system 214 embedded therein, wherein the footbed e-system214 comprises at least one micro controller unit (MCU) 250, a radarsensor subsystem (e.g., Transmitter Receiver Module (TRM) 252 and 260),a memory 254, and a battery 256. In various embodiments, the radarsensor subsystem includes a UWB sensor subsystem comprising a pulsegenerator, transceiver, and an antenna arrangement 60 to transmit thegenerated pulses and receive pulse echoes. In other embodiments, theradar sensor subsystem includes a TRM 252. In some embodiments, theantenna arrangement 60 can be embedded within the footbed 212, and inother embodiments, the antenna arrangement 60 can be secured to theouter surface 213 of the footbed 212 and extend the length and width ofthe user's foot, for example. In still other embodiments, the antennaarray 60 is positioned as a standalone object apart from an orthoticinsole or insert 216 and apart from the footbed 212, or secured to theinsole 216 (as shown in FIG. 17, for example). Regardless, the radarsensor subsystem is communicatively coupled to the footbed body 212having the e-system 214. In various embodiments, the insole 216comprises materials designed to optimize transparency to the generatedpulses and echoes. The insert 216 can also be designed as a heat sinkthereby improving the efficiency of the energy harvesting subsystemwhile providing the added effect of regulating foot temperature.

The antenna arrangement 60 can comprise a single antenna or an antennaarray, including a fractal antenna array, for example. The antennaarrangement 60 can further comprise a configurable array of fractalantennas. It will be appreciated that the system is capable of operatingin a passive mode using radio frequencies generated from sources otherthan the radar sensor subsystem, such as, for example, ultra-highfrequency (UHF), super-high frequency (SHF), very-high frequency (VHF),and extremely high frequency (EHF) bands. The system is also capable ofoperating in an active mode generating pulses, and is further capable ofdetermining when to switch between passive and active modes.

In various embodiments, a communications subsystem is provided as partof the footbed e-system 214. The communications subsystem can comprisehardware and software as embodied in wireless MCU 250 in FIG. 15 (andembodied in MCU 250 and wireless transceiver 255 in FIGS. 16 and 17),enabling communication from the e-system 214 in the footbed 216 to acomputing device, such as a mobile communications device (e.g., smartphone) 90, a laptop, desktop, tablet or other computing device 92. Invarious embodiments, the communications subsystem comprises hardware andsoftware enabling communication from the e-system in the footbeddirectly or indirectly to a central server 20 for use with the system ofthe present invention. Further, various embodiments incorporate aninter-insole transceiver 57 as part of the communications subsystem topermit communications back and forth between insole pairs associatedwith a user's pair of shoes, for example. The communications subsystemand/or radar sensor system can incorporate a separate transceiver usinga wireless standard to facilitate this operation, such as Zigbee or 900MHz, in various embodiments of the invention.

In various embodiments, the footbed e-system 214 further comprises anenergy harvesting subsystem 262 and an inertial measurement subsystem(IMU) 264, as described elsewhere herein. The system of the presentinvention can use data from the IMU to compensate for variations inantenna orientation from the antenna array 60, according to aspects ofthe present invention. In various embodiments, the footbed e-system 214can be embedded within the footbed 212 during an additive or other formof fabrication process. For example, a first portion of the footbed canbe printed, manufactured and/or generated, then the e-system can beembedded in the first portion, and then a second and any subsequentportions of the footbed can be printed, manufactured and/or generatedand joined with the first portion so as to enclose the e-system withinthe footbed. Further, in various embodiments, the footbed 212 can besecured to an orthotic (e.g., insole) 216 by providing a registrationsystem for maintaining alignment of the footbed 12 and the orthotic 216.As shown in FIGS. 13 and 14, for example, the insole/orthotic 216,footbed 212, and any layers between the insole/orthotic and footbed(such as array 60) include one or more methods for preventinginter-layer movement, such as a registration system. As illustrated inFIGS. 13 and 14, registration posts 232 are provided in one body (e.g.,the footbed 212) and mating registration openings, indentations or holes234 in another body (e.g., the orthotic 216 and array 60) such that,when mated, the posts 232 engage the openings 234 to retain the bodies212, 216, 60 together. A wiring/registration duct 236 can also beprovided to facilitate registration and communication among variouscomponents in the device 100. The registration system according toembodiments of the present invention prevents relative movement betweenthe footbed 212 and the insole/orthotic 216. As shown in FIG. 1, theregistration system supports implementable sensor arrays 60 by providinga method for connecting these arrays (e.g., 60) to the footbed e-system214. The registration system can also facilitate the connection of anyother electronics housed in or on the insole/orthotic 216 to thee-system in the footbed 214.

According to various embodiments, a cover 219 can be provided on theinsole 216 to protect the insole 216, protect any electronics housed inor on the insole 216 and to provide a desirable surface for a user whois wearing either socks or no other clothing between the user's barefoot and the insert. In various embodiments, the cover 219 may be a 3Dfabricated material that is fabricated during the manufacturing processor applied as part of the assembly process according to aspects of thepresent invention. The cover 219 can also function as an energyharvesting subsystem which is capable of interfacing with the e-system214 in the footbed 212 to charge the device 100 in-situ. In variousembodiments, the cover can employ a fabric that converts heat and motioninto electricity based on thermoelectric principles. In one embodiment,a cover fabric can be provided by International Thermodyne of Charlotte,N.C., USA. The device 100 can act as a heat sink to improve theefficiency of the cover's ability to generate electricity. A byproductof this arrangement is that the user's foot can be warmed and cooled asdesired. The generated electricity can be used to charge the battery 256via the wiring/registration duct 236 in the device 100, and can furtherbe integrated with power management component 280 to regulate andmonitor the generated electricity and charge of the battery 256.

In an exemplary embodiment, as shown in FIGS. 15 through 17, a deviceaccording to the present invention can include an induction chargingplate 270 for charging insoles associated with the present invention.The induction charging plate 270 can be connected to an alternatingcurrent (AC) power source, wherein an AC converter 272 can auto-detectthe voltage. In various embodiments, the induction charging plate can bepowered from a powered USB computer interface 274 connected to a USBport 276 on the plate 270. The plate 270 is capable of accommodating110/220 volt 50/60 Hz power sources, for example. Insoles contained intarget shoes can be removed and matched to insoles provided as part ofthe device of the present invention such that, using the existing insoleas a template, a user can trim the device's insoles to fit the targetshoes. The user places the device's insoles into the target shoes andplaces them on the induction charging plate 270. The induction chargingplate 270 recognizes the presence of the insoles and begins the chargingprocess using an induction transmitter 277 transmitting the charge tothe induction receiver 278 on the footbed 212. A related softwareapplication can track the charging status of the insert(s) and notifythe user, for example, should the user activate this option. Theinduction charging plate 270 and battery 256 can form elements of apower management component 280 on the footbed 212. The power managementcomponent 280 can also communicate the charge status for the inserts tothe server 20 or a separate computing device 90, 92 associated withaspects of the present invention.

When the inserts have charged sufficiently, a diagnostic test can beperformed to confirm that the e-system circuitry is performing withinspecification. The inserts can pair with a target smart device 90 orother computing device 92 via a wireless protocol, such as Bluetooth,for example. The diagnostic then tests the sensor array 60 to identifyany missing or failing sensors. The device remaps the sensors,determines if the array can perform within specification and to whatextent. The device creates and stores a diagnostic log and notifies theuser. If the device is not performing within specification, the user isgiven the option to continue using the device, view the diagnosticreport, and/or upload a report to an associated service center forresolution. Once the diagnostic testing is successfully passed, theinserts finish charging and a progress report and/or alert can be sentto the user when charging is complete.

The user then places the shoes on his/her feet and follows a calibrationprocess as specified by the mobile application, for example. Uponcompletion of the calibration process, the user performs a desiredactivity such as exercise, work, recreation or stress test, for example,while the footbed collects and stores data from the IMU and radarsensors and uploads it to the user's smart device for preliminaryprocessing. The data can independently be delivered to one or moreassociated servers for preliminary and primary processing. Communicationfrom the footbed 12 to the smart device 90 or computing device 92 canoccur via a wireless MCU 250, as shown in FIG. 15, or via a wirelesstransceiver 255 that is part of footbed 212 communicating with awireless transceiver 282 combined with a wireless router 284 that arepart of a wireless gateway 86 associated with embodiments of the presentinvention, as shown in FIGS. 16 and 17.

It will be appreciated that the data can be processed locally and/orremotely providing the user both real time biofeedback (should thisoption be selected) and performance data and post event results. Thisbiofeedback can be tailored by the analytics component 23 of server 20,for example, to reduce the risk of repetitive stress injuries,accelerate rehabilitation, and optimize performance, as describedelsewhere herein. The biofeedback is based on real time and historicalbiometric, musculoskeletal, and environmental data and user goals andobjectives, which can be stored in and accessed from database 33. Theuser can select to share the collected data with one or more individualssuch as HWF professionals, peers, family and friends, for example, viaadmin component 21 of server 20. The user can also create activityprofiles and share data based on activity and an individual or groups ofindividuals via admin component 21 of server 20. The user can alsochoose to share their de-identified data with HWF professionals andresearchers through a database and related service focused on improvingdiagnostic and treatment via admin component 21 of server 20.

In various embodiments, a device 100 according to the present inventioncan be worn as an insole in footwear, either as an accessory replacingpre-existing insoles or integrated into new footwear. Such a devicemeasures a wide range of physical and biometric parameters over the heel296, mid-foot/arch 297 and forefoot 298 portions of a user's foot, asshown in FIG. 13, for example. These parameters, when analyzed by theanalytics component 23, can be used to improve the design andmanufacture of custom orthotics, track orthotic-shoe performance,predict and mitigate repetitive stress injuries, optimizerehabilitation, exercise and training, and performance, improvediagnostic and treatment capabilities, extend HWF to disadvantagedindividuals through telemedicine and provide emergency response, forexample.

In various embodiments, a user can first remove the insoles in theirexisting shoes. Next, one at a time, the user can place the existinginsole back-to-back with the device's insole and trim the device'sinsole to match the existing insole. The user does not need to worryabout damaging the sensors associated with the invention's insole as thesensor array is self-healing and can be re-mapped during the diagnosticprocess. It should be noted that the user can complete this step with orwithout the footbed in place. In the embodiment of the present inventionemploying a registration system of pegs in the footbed with holes in theinsole, if the user prefers to trim the invention's insole without theassociated footbed, then the user can snap the orthotic back into thefootbed matching the registration holes in the insole with theregistration pegs on the footbed. It will be appreciated that theregistration system can incorporate a hook-and-loop type of fasteningarrangement and could be 3D printed as part of the component in variousembodiments of the present invention.

The registration system also acts as an interface between the footbede-system 214 and the sensor array 60 should the sensor array 60 besurface mounted to the insole 216, as illustrated in FIG. 13. Theregistrations posts 232 also inhibit movement of the orthotic insole andfootbed in the shoe. It will be appreciated that no trim-to-fit processis required in various embodiments of the present invention. Once theinvention's insole has been trimmed to fit and re-installed into theshoe, the shoe is placed on the induction charging plate 270. Theinduction charging plate 270 may or may not be plugged in. If theinduction charging plate is not connected to an AC power source 272,then the user connects the induction charging plate through a USBinterface 274 to an AC power source. The induction charging plate 270will either wake-up from a sleep mode, if already connected to an ACpower source, detect the invention's insole and begin charging or, inthe case of the former scenario run a diagnostic, enter the ready state,detect the invention's insole and begin charging. During charging, avisual gauge on the charging plate can indicate progress. Once theinvention's insole has charged sufficiently it will run a diagnosticthat tests all circuitry, tests the sensors and sensor array, stores adiagnostic report then pairs with the user's smart device 90 and orcomputer 92, at which point the user will receive a diagnostic reportand charging status, as noted above. If the user interface provided aspart of admin component 21 of the system 40 is open, the user can see avisual progress bar/fuel gauge and diagnostic status at any time, forexample.

The diagnostic process associated with administrative component 21 canre-map the sensor array 60 based on missing sensors resulting from thefitting process. It can also identify any inoperative or failingsensors, remap the array, assess any changes in data quality, and notifythe user through the diagnostic report. Should a sensor becomeinoperative or begin to fail during use, the system will adjust, assessany changes in data quality, and notify the user. Upon completion of thediagnostic process, the user puts on the shoes. The insoles lead theuser through a calibration process which can also be initiated manuallyby the user through a mobile application provided as part of usercomponent 21, for example. Upon completion of the calibration process,the user performs his/her activities. The user has the ability to setup/select activity profiles via admin component 21 and use them to setapplication behavior such as parameter tracking, data visualization, andbiofeedback, for example. Regardless of the selected profile, all datais collected by and stored in the database 33, and can be uploaded to asmart device 90 and/or other computing device 92. Cloud-based serverscan also be employed as direct or indirect recipients of the data. Thedata collection, storage, and processing can occur while the userperforms a desired activity or activities and or post-event. The usercan view any of the parameters tracked and resulting insight if theyhave a related widget from widget component 22 assigned to theiraccount, such as through a subscription, for example. If the userdesires to view data associated with a parameter not currently tied totheir account, the user can obtain a new widget, such as by purchasing asubscription for the associated widget or swapping out an existingwidget for the new one, for example. In the case of an orthoticassessment, the analytics component 23 will analyze the related data,determine the need for an orthotic, and if needed, the design component27 can design a custom orthotic based on the data collected, historicaldata, and, if appropriate, user base data related to similar activities.

In the case of a user needing a custom orthotic, the system 40 cangenerate a report via design component 27 illustrating and detailing thedesign, explaining the rationale, providing data and insight related tothe associated parameters, and offering the user the option to sharethis data with designated individuals within their community, and theoption of purchasing the custom orthotic.

In various embodiments, the manufacturing component 28 according toaspects of the system 40 of the present invention selects theappropriate materials from the system's materials library (stored indatabase 33, for example), and determines whether a single or mixedmaterial design best suits the design. Further, the manufacturingcomponent can determine the appropriate material constituency for theorthotic. In the case of a single material design, the manufacturingcomponent 28 determines the appropriate structural variations that bestmeet the design criteria. In the case of a mixed material solution, themanufacturing component 28 determines the appropriate mix, placement,distribution, and densities of each material and related structuralvariations. Embodiments of the distribution component 29 of the system40 provide automated supply chain management across the product'slifecycle from manufacturing, fulfillment, after sales support, andend-of-life.

In various embodiments, the system 40 according to aspects of thepresent invention improves its capabilities over time and as the userbase and user data increases, as described elsewhere herein. When thenew custom orthotics are complete, the user is notified and asked toconfirm the delivery option, which is then executed. In all use cases,the user has the ability to select what data they want to share. Onceselected, recipients receive an invitation to download the mobile and orweb application, set up an account, user profile, activity profiles, andcommunity through administrative 21 components. The system 40 canautomatically connect individuals that have received and acceptedinvitations. Recipients, such as healthcare professionals, can identifythe parameters they want to track, set notification thresholds for eachparameter and associate actions with notifications and set defaultactions based on notification characteristics via admin component 21.

In various embodiments, aspects of the present invention provide amodular insert device, expert system with mobile and web basedinterfaces, and a distributed manufacturing system, which can employadditive, subtractive or combined additive-subtractive manufacturing.

As described herein, embodiments of the present invention thus canprovide a modular orthotic device including a footbed 212 containing atleast one e-system 214, and a replaceable orthotic insole 216. Thecustom orthotic can be designed to be worn with or without the footbedgiving the user the ability to have multiple orthotics without having tohave multiple footbeds. The user can combine the footbed with theorthotic at any time, should the user want to collect data related tothat orthotic and shoe. The footbed and standard orthotic can beconstructed using additive or subtractive printing, or hybridadditive/subtractive printing, for example. In various embodiments, theantenna array 60 associated with the sensor system can be printed aspart of the footbed additive manufacturing process. The orthotics 216can be either constructed of a single material or mixed material. In thecase of the former, the structure is modified to create the desiredproperties. In the latter selection, placement, quantity, density, andstructure of the various materials are used to create the desiredproperties. These properties include, but are not limited to,resilience, flexibility, shock absorption, energy transmission,electrical conductivity, bacterial and odor resistance, thermalconductivity. The e-system 214 can be environmentally hardened by beingencapsulated within the footbed 212 during the manufacturing process, inone embodiment. The e-system-sensor array interface can optionallyemploy a quick-release mechanism that permits easy and quick replacementof the sensor array 60 or footbed 212, for example.

In various embodiments, the insole has two sensor systems, wherein thefirst is an inertial measurement system (IMU) consisting of a 3-axisaccelerometer, 3-axis magnetometer, and 3-axis gyroscope to measureorientation and location (e.g., by dead reckoning) and the second is aradar subsystem, such as an Ultra Wideband (UWB) imaging system. Unlikeother sensor technologies, the UWB sensor system accuracy does notrequire that the sensors be placed on the surface of the orthotic so thesensor array can be placed under the orthotic and still deliver clinicalgrade data. The UWB sensor system according to aspects of the presentinvention comprises a pulse generator, transceiver, and a configurablearray of fractal antennas to transmit the generated pulses and receivepulse echoes. The UWB sensor system can configure itself to minimizepower consumption, achieve the necessary resolution, and adjust avariety of parameters during, pre-, and post-data collection including,but not limited to, pulse rate, pulse duration, pulse strength,multiplexing such as orthogonal frequency division multiplexing (OFDM),multiple input multiple output (MIMO), beam forming, synthetic antennaaperture, combination of successive recorded echoes, auto-correlation,and image fusion.

In various embodiments, each insert device 100 has onboard memory usedto store sensor data and diagnostic logs for the purposes of backup,retransmission, and for post-event upload. Each insert has the abilityto communicate wirelessly with its insert mate and synchronizeactivities, as shown and described in connection with FIGS. 15 through17. Each insert can also communicate with smart devices 90, othercomputing devices 92, other wearable devices 94 and emergency services96 to upload sensor data and diagnostics for analysis. The system 40 canalso communicate with cloud-based servers. In various embodiments, thedevice 100 can connect directly with a cellular network to providelocation services and emergency response 96, for example. In variousembodiments, each insert has onboard memory 254, and can store sensorand diagnostic data using lossless data compression. In variousembodiments, each insert incorporates a thermodynamic energy harvestingsubsystem that is used to extend the life of the onboard battery 256 andprovide heating and cooling of the foot, as noted elsewhere herein.Additionally, each insert can support induction charging via device 270as noted elsewhere herein.

In various embodiments, the insert's embedded processor 250 managesinsole functionality including, but not limited to, on, off, sleep,energy management, charging, calibration, diagnostics, transceiving,pairing, inter-insole synchronization, sensor fusion algorithmsconverting IMU data into quaternions and data storage, for example.Further, each insert can adjust sensor resolution and sample rate byzone and identify failed and failing sensors, remap the sensor array,calculate the level of accuracy, compensate for degraded accuracy, andnotify user of changes, recommend actions, and notify customer support.Additionally, each insert can use algorithms such as provided viaanalytics component 23 of server 20 to constantly improve and optimizedata collection quality, determine system health, optimize itsperformance, protect data, and record system health and notify the userof future issues.

In establishing an account for use with embodiments of the presentinvention, a user can download a mobile web application provided throughthe administration component 21 to their device (e.g., 90 or 92),optionally create a user account and receive a validating message suchas an e-mail or text message with a link to their account associatedwith the system 40 of the present invention. The user can then accesstheir account and set up a password via admin component 21. The user canalso create a user profile, optionally multiple activity profiles, andoptionally their community members via admin component 21. The user canalso request that various software services by provided, such asindividual or bundled data widgets, for example, from widget component22. The user can further personalize their dashboard visual interfacevia admin component 21.

If the user is using the system 40 and device 10 according to aspects ofthe present invention to design a custom orthotic, then the system willnotify the user when it has sufficient data to execute the design basedon optimizing free motion and foot muscle activation, for example. Invarious embodiments, this may require a series of orthotics to reducedependency.

The system 40 can collect environmental, neurological, bio-mechanic,kinetic, and physiological data that is used in the evaluating the needfor and design of custom orthotics and assessing and improvingmusculoskeletal and physiologic performance, for example. In variousembodiments, the orthosis could be a single piece with the e-systemembedded in the orthotic or embedded in the orthotic in a way thatallows it to be removed should the orthotic need to be replaced. Thesensors, the orthotic, and the e-system can be disposable, or thee-system and sensors can be removed from an orthotic and installed intoa new orthotic, according to various embodiments of the presentinvention.

The system 40 can also generate a report via analytics component 23and/or design component 27, for example, that includes, but is notlimited to, showing the recommended custom orthotic, providing arationale behind the design, identifying risks for repetitive stressinjuries, and providing performance and performance improvement data andrecommendations, effectiveness assessments, and recommendations formeeting pre-determined goals and objectives. At the completion of theprocess, the user is offered the opportunity to upload the data to theirselected community members and purchase the custom orthotic via admincomponent 21. If the user chooses to purchase the orthotic, then theuser may proceed through an online transaction experience. Uponcompletion of the transaction, the distribution component 29 can locatethe nearest available or most suitable printer for the customer anduploads the file developed by the manufacturing component 28 forprinting. The user's order is confirmed and sent to the user along withdelivery options including an option to pick up the custom orthotics,such as through administrative component 21. The user can also be sentprogress reports from the administrative component 21 as the customorthotic is printed and prepared for delivery. Upon receipt of thecustom orthotics, the user can wear the custom orthotics 216 either withor without the footbed 212. In the former option, the user removes thedevice's inserts from the target shoes, removes the existing orthoticsfrom the footbeds and replaces them with the new custom orthotics. Itwill be appreciated in certain such instances that a physical spacer mayor may not have been in place within the shoe to take the place of wherethe footbed would have been. In the latter option, the user places theorthotics in the target shoes as with a traditional orthotic or insertsand uses the footbed with original or custom orthotics in another pairof shoes such as athletic shoes where the need for continuous datacollection, analytics, and biofeedback is greater.

The option to use the custom orthotic 216 with or without the footbed212 minimizes cost and gives the user flexibility. In the case of casualshoes, the user may only want to collect data on a periodic basis toconfirm the performance of the shoe and orthotic and determine if thereis a need to replace either.

FIG. 18 is a flow diagram illustrating specific processes associatedwith embodiments of the present invention as employed to develop anorthotic insole. As shown therein, a request is received by the systemto design an orthotic insert, as at 580, and appropriate data isrequested as at 582 by the system from libraries 33 as at 583, forexample. The data can be requested from libraries and includes datacollected by sensors located on the device or remotely from the device,for example. Once relevant data is captured, suitable parameters areimported as at 584, and an initial design is created as at 585. A reportand rationale for the design can be developed as at 586, and feedbackcan be solicited from a user as at 587. If feedback is provided, thedesign can be updated as at 588. If no feedback is provided, the usercan be presented the opportunity to buy and/or try a device manufacturedaccording to the created design, as at 589. If the user declines, thedesign can be saved as at 590 and stored in an appropriate library forlater use in step 583. If the user accepts, the design is also saved at590, and appropriate e-commerce activities transpire as at step 591,wherein the product is then manufactured at step 592 and distributed atstep 593. User feedback can be acquired by the system at step 594,including sensor-obtained feedback and/or qualitative user feedback, andsuch feedback is further stored in an appropriate library for later usein step 583.

FIG. 19 illustrates a user interface 1000 associated with embodiments ofthe present invention, such as may be employed in connection with acustom orthotic insole, for example. As shown therein, the userinterface 1000 includes widgets for roll 1002, pitch 1004 and yaw 1006foot movements, as well as widgets for line of balance 1008 and impulse1010 data. An elapsed time graph 1012 is also shown, along with a stepscounter 1014 and foot pressure map with a heat-map type display 1016,indicating what portions of the user's feet are bearing the greatestweight. A user can use the system of the present invention to displaymany other widgets, and users may have different purposes associatedwith what is displayed on their customized user interface. For example,a HWF professional and an end user may wish to see different data.

FIGS. 20 through 37 illustrate additional interfaces associated withembodiments of the present invention, including exemplary widgets,widget use, and communicate options for a user tied to a user's personalnetwork, such as communications involving a HWF professional through acompliant (HIPPAA & HITECH) system, for example.

As specific examples, FIG. 20 illustrates a user interface 1100 showingoverall menu options for a user according to embodiments of the presentinvention, including a user home page, a personalized workout component,a personalized data component, a sharing component, a store component(such as to add widgets, for example), a settings component, and “help”and logout components. FIG. 21 illustrates a user interface 1110 showingwhich widgets a user is currently subscribed to, and which can be added,according to embodiments of the present invention. FIG. 22 illustrates auser interface 1120 similar to FIG. 21, with a particular widget, “shearreaction force”, having been added from the widget options according toembodiments of the present invention. FIG. 23 illustrates a userinterface 1130 showing five specific widget details and an icon 1132 fora user to add a widget according to embodiments of the presentinvention. FIG. 24 illustrates a user interface 1140 showing sixspecific widget details for a user according to embodiments of thepresent invention. FIG. 25 illustrates a user interface 1150 showing sixspecific widget details for a user, including a “calories burned” widget1152 replacing the “shear reaction force” widget 1142 of FIG. 24.

FIG. 26 illustrates a user interface 1160 showing a user's specificallytracked data according to embodiments of the present invention. FIG. 27illustrates a user interface 1170 showing widgets and details for a userprior to a workout according to embodiments of the present invention.FIG. 28 illustrates a user interface 1180 showing widgets and detailsfor a user during a workout according to embodiments of the presentinvention. FIG. 29 illustrates a user interface 1190 showing a user inthe process of saving a workout and/or related details according toembodiments of the present invention. FIG. 30 illustrates a userinterface 1200 showing a user in the process of saving a workout and/orrelated details using a file name, according to embodiments of thepresent invention. FIG. 31 illustrates a user interface 1210 showing aselection option for a user to share his or her workout, according toembodiments of the present invention. FIG. 32 illustrates a userinterface 1220 showing menu options for a user sharing his or herworkout according to embodiments of the present invention, including aselection option 1222 to send workout details to a team, a selectionoption 1224 to send workout details to a coach and a selection option1226 to send workout details to a physical therapist, for example. FIG.33 illustrates a user interface 1230 showing a confirmation message thata user's workout has been successfully shared with the user's physicaltherapist, according to embodiments of the present invention. It will beappreciated that the user's physical therapist can invoke subsequentoperations according to embodiments of the present invention, including,for example, tracking the user's progress against a therapy program.FIG. 34 illustrates a user interface 1240 showing statistical detailsfor a user tied to a specific widget (e.g., running pace 1242) accordingto embodiments of the present invention. FIG. 35 illustrates a userinterface 1250 showing the ability for a user to edit his or her widgetoptions according to embodiments of the present invention. FIG. 36illustrates a user interface 1260 showing the ability for a user toreview his or her widget options according to embodiments of the presentinvention. FIG. 37 illustrates a user interface 1270 showing options fora user to reveal more details about a particular widget from a set ofuser widgets, according to embodiments of the present invention.

Exemplary Use Case: Health-Wellness-Fitness (HWF) Professional

In accordance with various aspects and embodiments of the presentinvention, the system 40 can send a HWF professional an invitation fromthe user via a software application as part of the administrativecomponent 21 of the present invention. In various embodiments, the HWFprofessional may “subscribe” to the appropriate SaaS package or, as inthe case of a larger group, pick the appropriate package or data widgetsfrom the widget component 22 in accordance with embodiments of thepresent invention. The HWF professional can set up an account, profile,and community using the admin component 21 of the system of the presentinvention, wherein the community may include other HWF professional andtheir patients/clients, for example. The HWF professional can thenidentify the appropriate parameters to be tracked, set parameternotification thresholds, and notification actions for eachpatient/client and HWF professional associated with that patient/client.If the patient/client is not a user of the system of the presentinvention, then the HWF professional can invite the patient/client tobecome a user. In this case, the patient/client would go through thetypical on-boarding process. The system of the present invention canalso facilitate billing and insurance functions, for example, throughthe HWF professional's billing process and/or external systems 35 incommunication with the server 20 of the present invention.

The user, as part of the on-boarding process and via admin component 21,can opt-in to share their data with the HWF professionals identified bythe sponsoring HWF professional. The user has the ability to determinewho receives data, what data is shared, under what circumstances, andfor how long. For example, a user with a knee injury may decide to sharedata related to the knee injury and its rehabilitation with thephysician, physical therapist, personal trainer, and coach and makethose connections perishable based on when the system determines theknee has recovered, a specific date, or manually. The user also has theability to add or remove HWF professionals and others including sharingtheir de-identified data for research, for example. Users and HWFprofessionals also have the option of associating members of theircommunity to an issue, objective, goal profile. For example,musculoskeletal issue, running a ten kilometer race in thirty minutes,optimizing recovery, improving form, optimizing performance andbehavioral modification may all be part of a user's goal profile. TheHWF professional can, with the user's permission, use the user's realworld data to enhance diagnostic and treatment capabilities to assessprogress and efficacy and predict outcomes. The HWF professional can dothis based on a patient's/client's near-term and or historical data andor accessing the de-identified data of their patient/client base,patients/clients within their clinic's/medical system/network and or theentire user base of the system. It will be appreciated that only datafrom users that volunteer their de-identified information are includedin this database 33. The system can analyze all of the userde-identified data and input from HWF professionals to improve theinvention's capabilities and accuracy.

Exemplary Use Case: Retailers and Shoe Manufacturers

Shoe retailers and manufacturers can use the various embodiments of thepresent invention to create off-the-shelf custom fitting shoes usinguser provided data stored in database 33, for example. The user can beprovided with a rank-ordered list of functionally fitting shoes, forexample. The system according to aspects of the invention can determineif a custom orthotic design would optimize the fit and offers thisoption to the user. If selected, the custom orthotic is printed andadded to the shoe while the user waits, in the case of a brick andmortar scenario or shipped to the user, in the case of an onlinescenario. Manufacturers can employ various embodiments of the presentinvention into their shoes during the development and productionprocess. New users can then go through the typical process foridentifying the need for and design of a custom orthotic. In the case ofexisting users, a semi-custom or custom orthotic based on the user'sdata can be shipped as part of their new shoes.

In all scenarios, the retailer and manufacturer can create a masspersonalization model supporting a personalized shopping experience inaccordance with embodiments of the present invention. In the case wherea user or HWF professional has the appropriate equipment, an onlinelibrary of printable shoes can be maintained in database 33 and printedby the user, retailer or HWF professional, for example.

Exemplary Use Case: Athlete

Athletic coaches can use the real time data and analytics fromembodiments of the invention to track and assess a range of parametersin real-time and post-event including, but not limited to, athlete andteam performance, and performance optimization injury risk, exercise andtraining effectiveness. Aspects of the invention provide a personalizeddashboard as part of admin component 21 and/or coach component 30,giving users/HWF professionals information they need in the way thatmakes the most sense to them. Analytic processes available throughanalytical component 23 of the system of the present invention can bedesigned as widgets that can be used as groups or individually. Accessto visual dashboard administration and widget component 22 enablesselection of pre-bundled widgets and the entire library of individualwidgets. The user/HWF professionals can then manipulate (e.g., drag anddrop) the widgets to organize them to meet their need and the way theylike to receive information. Widgets can be manipulated, combined andcustomized using the widget optimizer component 25. The user/HWFprofessionals can further use optimizer component 25 to link widgets tocreate new information such as power by linking torque and rpm widgets,for example. Users/HWF professionals can choose to drill down intoincreasingly finer detail by clicking on a dashboard or widget, forexample. Embodiments of the system learn from the dashboard design anduser interaction to determine which insights are desired and torecommend dashboard designs to optimize interaction. The user/HWFprofessional also has the ability to use the interfaces associated withthe system of the present invention to select preferred datavisualization options including, but not limited to, color schemes,format, and representation, for example. The user/HWF professional canalso set these options as defaults by a range of attributes such asindividual patient/client/athlete, group/team, particularissue/goal/objective, performance. Defaults can be created and thesystem can pre-populate information to accelerate administrativefunctions.

Exemplary Use Case: Health/Disability Related Symptom Reduction

In various embodiments, the present invention can notify users/HWFprofessionals via administrative component 21 to risks such as footulceration in people with neuropathy, for example. Aspects of thepresent invention can also provide information to improve motor skillsin stroke victims and individuals with musculoskeletal issues such asmuscular dystrophy and cerebral palsy, for example, and can be used tomitigate symptoms of joint related issues such as arthritis and injury,for example. Aspects of the present invention can also provideinformation to assist people with autism in knowing when they arebecoming emotionally agitated so that they can perform calming routines,for example. In the case of age-related diseases such as dementia, inorder to mitigate falls, aspects of the present invention can alsoassist care givers and family members in remote monitoring. This caninclude preventing and predicting falls in the elderly, sendingnotifications to care givers and family members. The dead reckoningcapability allows care givers and family members to track at-riskindividuals in conjunction with or without other systems such as GPS,for example.

Exemplary Use Case: Occupational Health & Safety

In various embodiments, the system 40 provides a wearable, real-timesafety monitoring system that seamlessly integrates into the existingwork gear of industrial workers, healthcare professionals, constructionworkers, retail staff, knowledge workers, and/or the labor force as awhole. In various embodiments, the system 40 effectively records andanalyzes biometric and ergonomic data via analytics component 23 to helpcompanies predict and prevent injuries, and/or create a personalizedmusculoskeletal injury prevention and rehabilitation plan. From theprevention perspective, the analytics component 23 can assist companieswith site specific risk assessments, and can highlight which work sitescause the most injuries, which actions are high risk of injury, whichjob classifications have the highest risk of repetitive stress andmusculoskeletal injuries. The analytics component 23 can further assistin determining why these site, actions, and job classifications aresusceptible to injuries. The analytics component 23 according toembodiments of the invention can provide a personalized recovery planwith an internal alert and recommendation system, so an injured workercan return to work quickly and safely with a reduced chance ofre-injury. The analytics component 23 can also assist a company inreintegrating the recovering worker as quickly as possible. In variousembodiments, a worker can install the insert device as noted above andinclude the appropriate company personnel such as occupational healthand safety personnel in their community via admin component 21. Addingthe workers management extends the capabilities of the present inventionby letting management optimize the use of labor such as in theconstruction industry, for example. The system 40 can augment accidentprevention by providing employees biofeedback and analytics from bigdata to assist in personalizing accident prevention programs andmitigating risks.

Exemplary Use Case: Real Estate Optimization

Typical commercial office space is considered to be 70% underutilized,which has significant economic and environmental impact. Significanteffort goes into understanding how a company's space is being used toreduce costs and increase employee innovation, productivity, andefficiency. Currently, there is no one method that providesstatistically significant results and requires cross-correlation whichresults in great expense, time, and change management. Related somewhatto the Occupational Health and Safety discussion above, real estateoptimization can be supported by embodiments of the present invention.For example, the analytics component 23 of the present invention canallow a company to optimize its real estate portfolio by tracking spaceutilization and improve employee innovation, productivity, andefficiency by understanding what spaces are under and over utilized,when this occurs, and how the spaces are used. The resulting data alsosupports trend analysis, adjusting for regional differences andvariations in workforce characteristics.

Exemplary Use Case: Emergency Response/First Responders

Following the typical installation process, it will be appreciated thatembodiments of the present invention can track location based on globalpositioning systems (GPS), as well as via cellular, beacon or wirelesstechnologies, and/or dead reckoning using the IMU. Embodiments of theinvention can also provide biofeedback via analytics component 23 tomitigate the risk of repetitive stress injuries.

The system 40 according to embodiments of the present invention canreside both on an external/host computing device (e.g., 90 or 92) and onserver 20. The host device version provides real time processing insupport of biofeedback, communicates with the server-side system, andprovides a user interface between the insoles, the system back-end, datavisualization and insights, biofeedback, behavioral change tools,administrative functions, ecommerce, and groupware, for example. Thesystem can manage data, security, privacy, enterprise resource andsupply chain management, and includes the capability to learn, optimize,and improve through the application of artificial intelligence.

In various embodiments, the system 40 tracks and adjusts for any out ofsync data between the left and right insoles, identifies the cause ofthe misalignment, and, if possible, corrects the misalignment andnotifies the user of the misalignment and any resulting data qualityissues. In various embodiments, the system 40 uses data collected fromthe inserts 100 to perform a full gait analysis; predict musculoskeletalissues such as, but not limited to, repetitive stress injuries;accelerate rehabilitation, improve wellness, track and improveperformance, predict health and occupational safety risks; identifyfunctionally fitting shoes; determine the need for emergency responsesuch as alerting “911” services, caregivers, health-wellness-fitnessprofessionals; calculate altitude, heading, and reference to determinelocation. In various embodiments, the virtual coach component 30receives insole diagnostic data tracking its performance, optimizingdata quality and acquisition, providing system alerts andrecommendations with the ability to perform administrative functions inthe background based on user input. In various embodiments, the system40 stores data and analytics for all parameters regardless of theanalytics in use and can retroactively generate historical results fornewly introduced parameters. Further, the system 40 can learn the datapresentation preferences of the user and, based on user goals andobjectives, recommends data visualization options and insights to theuser, including those in the system 40 library that are not currentlybeing accessed by the user. When received by the system 40, the raw datais linked to the user's account, stored and processed through algorithmsand made available to the user based on their personalized dashboard viaadmin component 21.

In various embodiments, the system 40 accesses the user's availabledata, available de-identified user base data, and available contextualdata from database 33 to derive and share insights with the user. Thiscan be at the request of the user or offered by the expert system toaugment the user's awareness, diagnostic and treatment capabilities,and/or decision making. The system 40 emulates the diagnostic processesof HWF professional's skills in determining the need for and design ofcustom orthotics. The analytics component 23 uses the data collected bythe insert 10 to determine the user's free motion, and the designcomponent 27 then designs an orthotic to promote and optimize that freemotion should it be needed, optimize muscle activation and musclestrength, and, over time, minimize the need for an orthotic, forexample. The analytics component 23 can also integrate data from othersensors located on other parts of the body, such as via wearables 94, toimprove the accuracy of its assessment and orthotic design and otherpredictive functions. In various embodiments, system 40 can produce anincreasingly accurate musculoskeletal, biomechanical, and kinematicmodel of the user over time. The system 40 can then use these models,user historical data, user goals and objectives, and user base data toimprove the accuracy and speed of its assessments, suggestions,predictions, and orthotic design. The system 40 can determine if, when,and by how much an orthotic should be redesigned based on the user'sactivity, shoe, physical changes, and muscle usage, for example. Thesystem 40 can further determine if the user's shoes need to be replaced,predict risk of repetitive stress injuries and recommend mitigationstrategies and optimize rehabilitation, exercise, and performance. Thesystem 40 can further assess form and provide biofeedback during theactivity such as running or weight training to improve user form,optimize performance, and reduce the risk of injury. This capabilityextends to rehabilitation such as with stroke, arthritis, dementia, andneurological and musculoskeletal damage, for example. In variousembodiments, the system can also identify stress/agitation such as inautistic individuals and alerts them so that they can performde-stressing routines.

The system 40 can further recommend a form/style best suited to the useror assist the user in optimizing the user's form/style to a desiredform/style. This applies to foot-related activities, whether cycling,running, football, climbing a ladder, weight training, work,rehabilitation, and other activities. For example, the system 40 canrecommend a runner use the pose style or help a runner optimize theuser's form to the pose style. The system 40 can continuously assess therisk of injury and the capacity and capability for achieving maximumperformance and make recommendations to the user during and after theevent. The system 40 can identify functionally fitting shoes anddetermine changes in the user's orthotic to expand the range offunctionally fitting shoes, and can also measure orthotic-shoeperformance and notify the user when to replace the shoe and ororthotic. The system 40 can augment diagnostic and treatmentcapabilities by assessing a user's historical data collected by theinvention, accessing available de-identified data of a professional'spatient/client base, accessing available de-identified data ofpatients/clients within the HWF and OH&S systems supporting theprofessional, and accessing de-identified data made available by usersof the invention.

In various embodiments, the system 40 also recommends alternategoals/objectives based on the user's history, capacity, capability, andprogress restructuring the user's experience and motivators. In variousembodiments, the system 40 designs and manufactures a custom orthoticbased on data collected from an insole without any required humanintervention, including recommending construction parameters, such as amodular consistency, of a device to be produced, and/or creating anelectronic file with such recommended construction parameters. The datacan be processed by software to produce a 3D printable file of thecustom orthotic that may be transmitted to the most convenient and/orsuitable manufacturing device for creation.

It will thus be appreciated that, among other things, the presentinvention can include one or more digital libraries containing datarepresentations facilitating embodiments of the present invention asdescribed herein. For instance, certain digital libraries can assistwith system optimization, HID creation, HID object selection,simulation, evaluation, object modification and digital materialization.

Specifically, a user profile digital library can provide demographic,biometric and biomechanical data, for example. An idealized form librarycan provide data on top performance, zero RSI risk, and may notnecessarily be personalized to the user. A preferred form library canprovide data on a personalized idealized form and optimized free motion,for example. An actual form library can provide continuous datarepresented by the root and calculated parameters. A community librarycan provide data regarding a user-created network. A scraping librarycan provide web harvesting and data extraction, for example. A HWFlibrary can provide quantification of qualitative data, observations andmeasurements, for example. An external feedback library can quantifyuser/third party qualitative data, observations and measurements. Abiofeedback library can provide user, system and HWF definednotification thresholds providing real time feedback and alerts. A userfeedback library can provide quantification of qualitative data,observations and user measurements, for example. An activity profilelibrary can provide a collection of signatures defining differentactivities, for example. An environmental library can provide climate,topography and surface conditions of the user's immediate surroundings,for example.

A neurology library can provide data on nervous system performance, forexample. A physiology library can provide data on biological systems,such as respiratory, cardiovascular and blood chemistry, for example. Aphysiological model library can define user physiological models, suchas, oxygenation, blood chemistry, neurological, cardiovascular, muscleactivation and respiratory performance, for example. A kinematic modelslibrary can define a user's motion, and a biomechanical models librarycan define a user's musculoskeletal structure, for example. A resultslibrary can provide data related to a given activity such as a sport,work or recreation, for example. A digital materialization (DM) librarycan provide a solve process incorporating materials, shape, behavior andmanufacturing data, for example. A sensor data library can include datacollected from wearable devices, such as orientation, force, biometricdata and neurological data, for example. A parameters library canprovide values directly or indirectly derived from data where indirectlyderived data comes from a combination of directly derived values.

An analytics library can provide algorithms using a set of parameters toprovide information and insights such as gait analysis, injuryprevention, RSI prediction, diagnosis, treatment, rehabilitiation,performance optimization, emotional state, and processes, for example. Avirtual coach library can provide recommendations to users on one ormore optimal paths to objectives and mitigation of risks, including thecollection of boundaries to define the acceptable range of a givenactivity or objective (e.g., RSI risk reduction, diagnostics, treatment,rehabilitiation, stress management, performance optimization). Amaterials library can provide a collection of properties associated withspecific material-structure combinations. A shape library can providecontour data related to an object, for example. A behavior library canprovide predicted performance of a digital materialization and/ordynamic digital materialization object for a scenario, includinginstructions for adapting a device, for example. A manufacturing anddistribution library can provide details on tool capabilities andconstraints, locations and availability of manufacturing resources, costand time data and user location data, for example.

It will be appreciated that all of the disclosed methods, analytics, andprocedures described herein can be implemented using one or moreprocessing devices, computer programs or components, such as the serverin FIG. 1. These components may be provided as a series of computerinstructions on any conventional computer-readable medium, includingRAM, ROM, flash memory, magnetic or optical disks, optical memory, orother storage media. The instructions may be configured to be executedby one or more processors which, when executing the series of computerinstructions, performs or facilitates the performance of all or part ofthe disclosed methods, analytics, and procedures.

Unless otherwise stated, devices or components of the present inventionthat are in communication with each other do not need to be incontinuous communication with each other. Further, devices or componentsin communication with other devices or components can communicatedirectly or indirectly through one or more intermediate devices,components or other intermediaries. Further, descriptions of embodimentsof the present invention herein wherein several devices and/orcomponents are described as being in communication with one another doesnot imply that all such components are required, or that each of thedisclosed components must communicate with every other component. Inaddition, while algorithms, process steps and/or method steps may bedescribed in a sequential order, such approaches can be configured towork in different orders. In other words, any ordering of stepsdescribed herein does not, standing alone, dictate that the steps beperformed in that order. The steps associated with methods and/orprocesses as described herein can be performed in any order practical.Additionally, some steps can be performed simultaneously orsubstantially simultaneously despite being described or implied asoccurring non-simultaneously.

It will be appreciated that algorithms, method steps and process stepsdescribed herein can be implemented by appropriately programmed generalpurpose computers and computing devices, for example. In this regard, aprocessor (e.g., a microprocessor or controller device) receivesinstructions from a memory or like storage device that contains and/orstores the instructions, and the processor executes those instructions,thereby performing a process defined by those instructions. Further,programs that implement such methods and algorithms can be stored andtransmitted using a variety of known media. At a minimum, the memoryincludes at least one set of instructions that is either permanently ortemporarily stored. The processor executes the instructions that arestored in order to process data. The set of instructions can includevarious instructions that perform a particular task or tasks. Such a setof instructions for performing a particular task can be characterized asa program, software program, software, engine, module, component,mechanism, or tool. Common forms of computer-readable media that may beused in the performance of the present invention include, but are notlimited to, floppy disks, flexible disks, hard disks, magnetic tape, anyother magnetic medium, CD-ROMs, DVDs, any other optical medium, punchcards, paper tape, any other physical medium with patterns of holes,RAM, PROM, EPROM, FLASH-EEPROM, any other memory chip or cartridge, orany other medium from which a computer can read. The term“computer-readable medium” when used in the present disclosure can referto any medium that participates in providing data (e.g., instructions)that may be read by a computer, a processor or a like device. Such amedium can exist in many forms, including, for example, non-volatilemedia, volatile media, and transmission media. Non-volatile mediainclude, for example, optical or magnetic disks and other persistentmemory. Volatile media can include dynamic random access memory (DRAM),which typically constitutes the main memory. Transmission media mayinclude coaxial cables, copper wire and fiber optics, including thewires or other pathways that comprise a system bus coupled to theprocessor. Transmission media may include or convey acoustic waves,light waves and electromagnetic emissions, such as those generatedduring radio frequency (RF) and infrared (IR) data communications.

Various forms of computer readable media may be involved in carryingsequences of instructions associated with the present invention to aprocessor. For example, sequences of instruction can be delivered fromRAM to a processor, carried over a wireless transmission medium, and/orformatted according to numerous formats, standards or protocols, such asTransmission Control Protocol/Internet Protocol (TCP/IP), Wi-Fi,Bluetooth, GSM, CDMA, EDGE and EVDO. Where databases are described inthe present disclosure, it will be appreciated that alternative databasestructures to those described, as well as other memory structuresbesides databases may be readily employed. The drawing figurerepresentations and accompanying descriptions of any exemplary databasespresented herein are illustrative and not restrictive arrangements forstored representations of data. Further, any exemplary entries of tablesand parameter data represent example information only, and, despite anydepiction of the databases as tables, other formats (includingrelational databases, object-based models and/or distributed databases)can be used to store, process and otherwise manipulate the data typesdescribed herein. Electronic storage can be local or remote storage, aswill be understood to those skilled in the art. Appropriate encryptionand other security methodologies can also be employed by the system ofthe present invention, as will be understood to one of ordinary skill inthe art.

The invention may be embodied in other specific forms without departingfrom the spirit or essential characteristics thereof. The presentembodiments are therefore to be considered in all respects asillustrative and not restrictive, the scope of the invention beingindicated by the claims of the application rather than by the foregoingdescription, and all changes which come within the meaning and range ofequivalency of the claims are therefore intended to be embraced therein.

The invention claimed is:
 1. A method for using a computer system todesign a human interacting physical device, comprising: electronicallyreceiving, by a computer system, data defining characteristics of atleast a portion of a first device to be formed or modified, wherein thedata is received from one or more sensors mounted to a second device,and wherein the data relates to one or more specific human bodies;searching, by the computer system and based on the received data, one ormore digital libraries for an object corresponding to the first device,and retrieving at least a shape characteristic and a materialconstituency characteristics associated with the object; evaluating, bythe computer system and based on the received data, whether the shapecharacteristic or the material constituency characteristic of the objectrequires adaptation in order to produce the first device; determining,by the computer system, whether the shape characteristic or the materialconstituency characteristic of the object requires adaptation to be anoptimized design for the first device; upon the shape characteristic orthe material constituency characteristic of the object requiringadaptation, simulating, by the computer system and based on the receiveddata, one or more changes in the shape characteristic and one or morechanges in the material constituency characteristic of the object;storing, by the computer system, object design characteristicscomprising at least one of the simulated changes in the shapecharacteristic or in the material constituency characteristic of theobject in the one or more digital libraries; and generating a design forthe first device based upon the stored object design characteristics. 2.The method of claim 1, including the further step of generatingmanufacturing or modifying instructions and manufacturing or modifyingthe first device based on the object design characteristics usingadditive manufacturing, subtractive manufacturing or a combination ofadditive and subtractive manufacturing.
 3. The method of claim 1,wherein the second device comprises at least one morphable physicalattribute controlled by a controller associated with the second device,and receiving, by the controller associated with the second device,instructions associated with the object design characteristics in orderto morph the second device.
 4. The method of claim 1, including the stepof using the stored object design characteristics to design the firstdevice for a different human body from the one or more specific humanbodies.
 5. The method of claim 1, wherein the data definingcharacteristics of the first device is received from one or more sensorsmounted to multiple areas of the second device.
 6. The method of claim1, wherein the one or more sensors include a radar sensor subsystemcomprising one or more of a pulse generator, transceiver, and an antennaarrangement to transmit generated pulses and receive pulse echoes. 7.The method of claim 1, wherein the design is based on at least one of:ergonomics, improving physical performance, avoiding injury, andacceleration rehabilitation.
 8. The method of claim 1, furthercomprising the step of designing at least a second device tointeroperate with the first device.
 9. The method of claim 8, includingthe steps of: providing at least a first sensor collecting dataassociated with the use of the first device or the performance of a userof the first device; providing at least a second sensor collecting dataassociated with the use of the second device or the performance of auser of the second device; and providing, by the system, based on thedata associated with the use of the first or second device at least onerecommended adaptation to one of the first or second devices.
 10. Themethod of claim 2, including the steps of: providing at least one sensorcollecting data associated with the use of the first device or theperformance of a user of the first device; and providing, by the system,based on the data associated with the use of the first device or theperformance of a user of the first device, at least one recommendedadaptation to the first device.
 11. The method of claim 10, includingmanufacturing the first device with the recommended adaptation usingadditive manufacturing, subtractive manufacturing, or a combination ofadditive and subtractive manufacturing.
 12. The method of claim 1,wherein the step of searching includes searching for most closelysimilar objects from a database of commercially available objects. 13.The method of claim 1, wherein the step of receiving data definingcharacteristics comprises receiving an instruction related to at leastone of: improving physical performance, reducing pain, rehabilitation,predicting injury, adapting physical performance to match a definedhuman individual, and product evaluation.
 14. The method of claim 1,wherein the evaluating step comprises evaluating at least one of: cost,time, individual user fit, environment, and manufacturing.
 15. A methodfor using a computer system to design a human interacting physicaldevice, comprising: electronically receiving data definingcharacteristics of a first device to be formed or modified, wherein thefirst device is of a first type, and wherein the data is received fromone or more sensors mounted to a second device of the first type, andwherein the data relates to one or more specific human bodies; searchingone or more digital libraries, based on the received data, for an objectof the first type, and retrieving at least a shape characteristic and amaterial constituency characteristic associated with the object;determining, by the computer system, whether the shape characteristic orthe material constituency characteristic of the object requiresadaptation to be an optimized design for the first device; simulating,by the computer system and based on the received data, one or morechanges in the shape characteristic and one or more changes in thematerial constituency characteristic of the object; and generating adesign for the first device based on the simulated changes and thereceived data, wherein the design comprises manufacturing or modifyinginstructions and object design characteristics, wherein the objectdesign characteristics comprise at least one of the simulated changes inthe shape characteristic or in the material constituency characteristicof the object.
 16. The method of claim 15, further includingtransmitting the object design characteristics to an additivemanufacturing component, subtractive manufacturing component, orcombination additive and subtractive manufacturing component forfabricating or modifying the first device defined by the object designcharacteristics.
 17. The method of claim 16, including the steps of:providing at least one sensor collecting data associated with the use ofthe first device or the performance of a user of the first device; andproviding, by the system, based on the data associated with the use ofthe first device or the performance of a user of the first device, atleast one recommended adaptation to the first device.
 18. A customhuman-interacting device manufacturing system, comprising: one or moresensors mounted to a first device of a first type, with the one or moresensors comprising at least a battery, a transceiver and an antennaarray; an e-system in wired or wireless communication with the one ormore sensors, and configured to perform signal processing, controlprocessing and remote device communication; a remote device comprisingat least one processor and memory storing instructions, executable bythe processor, to receive data defining characteristics of a seconddevice to be formed or modified, wherein the second device is of thefirst type, wherein the data is received from the one or more sensorsvia the e-system, and wherein the data relates to one or more specifichuman bodies; search one or more digital libraries, based on thereceived data, for an object of the first type, and retrieve at least ashape characteristic and a material constituency characteristicsassociated with the object; determine whether the shape characteristicor the material constituency characteristic of the object requiresadaptation to be an optimized for the second device; simulate, based onthe received data, one or more changes in the shape characteristic andone or more changes in the material constituency characteristic of theobject; and store manufacturing instructions and object designcharacteristics comprising at least one of the simulated changes in theshape characteristic or in the material constituency characteristic ofthe object in the one or more digital libraries; and a manufacturingdevice for generating or modifying a design of the second device basedon the stored object design characteristics and the manufacturinginstructions.
 19. The system of claim 18, wherein the one or moresensors further comprise a signal control processor.
 20. The system ofclaim 18, wherein the one or more sensors further comprise an inertialmeasurement unit.
 21. The system of claim 18, wherein the one or moresensors further comprise a signal control processor and an inertialmeasurement unit.
 22. The system of claim 18, wherein the manufacturingdevice employs additive manufacturing, subtractive manufacturing, or acombination of additive and subtractive manufacturing.
 23. A customhuman-interacting device design system, comprising: one or more sensorsmounted to a first device of a first type, with the one or more sensorscomprising at least a transceiver and an antenna array; an e-system inwired or wireless communication with the one or more sensors, andconfigured to perform signal processing, control processing and remotedevice communication; a remote device comprising at least one processorand memory storing instructions, executable by the processor, to receivedata defining characteristics of a second device of a second type to beformed, wherein the data is received from the one or more sensors viathe e-system, and wherein the data relates to one or more specific humanbodies; search one or more digital libraries for an object of the secondtype based on the received data, and retrieve at least a shapecharacteristic and a material constituency characteristics associatedwith the object; determine whether the shape characteristic or thematerial constituency characteristic of the object requires adaptationto be an optimized design for the second device; simulate, based on thereceived data, one or more changes in the shape characteristic and oneor more changes in the material constituency characteristic of theobject; store manufacturing instructions and object designcharacteristics comprising at least one of the simulated changes in theshape characteristic or in the material constituency characteristic ofthe object in the one or more digital libraries; and a controller forgenerating or modifying a design for the second device based on thestored object design characteristics and the manufacturing instructions.24. The system of claim 23, wherein the second device comprises at leastone morphable physical attribute controlled by the controller, andwherein the remote device receives, from the controller, instructionsassociated with the object design characteristics in order to morph thesecond device.
 25. The system of claim 23, including the step of usingthe stored object design characteristics to design the first device fora different human body from the one or more specific human bodies.